Study to Evaluate Efficacy and Safety of E-101 Solution f... | NCT01297959

Name	Class
Veristat, Inc.	OTHER
Biotec Services International Ltd	OTHER
Eurofins	INDUSTRY
CBR International Corp.

Label	Type	Description	Intervention Names
E-101 Solution 300 GU/mL	Experimental	Participants will receive E-101 Solution at porcine myeloperoxidase (pMPO) concentration of 300 guaiacol units per milliliter (GU/mL) applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.	Drug: E-101 Solution 300 GU/ml
Placebo (Saline solution)	Placebo Comparator	Participants will receive placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.	Drug: Saline solution

Name	Type	Description	Arm Group Labels	Other Names
E-101 Solution 300 GU/ml	Drug	8 mL of E-101 Solution	E-101 Solution 300 GU/mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants In Intent to Treat (ITT) Analysis Set With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving Principal Incision Within 30 Days After Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively	Superficial SSI: purulent drainage (PD) from superficial incision (SI), organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from principal incision (PI), or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on Clinical Infection Wound Scale (CIWS). Deep incisional SSI: PD from deep incision (DI) but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.	Surgery (Day 0) up to 30 days post-surgery
Number of Participants In Per-Protocol (PP) Analysis Set With Superficial and Deep Incisional SSI Involving Principal Incision Within 30 Days After the Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively	Superficial SSI: PD from SI, organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from PI, or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on CIWS. Deep incisional SSI: PD from DI but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.	Surgery (Day 0) up to 30 days post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Mean Clinical Infection Wound Scale Score (CIWS)	CIWS was used postoperatively to evaluate the primary incisional wound for clinical evidence of infection. Score ranged from 0 (normal) - 5 (worst). 0: normal post-operative wound appearance, 1: wound erythema with pain extending ≥ 2 cm away from the primary incision, 2: spontaneous wound dehiscence with erythema and/or pain extending < 2 cm along primary incision, 3: spontaneous wound dehiscence with erythema and/or pain extending ≥ 2 cm along primary incision, 4: PD from the primary incision, 5: infection of primary incision involving deep incisional structures (muscle and/or fascia) manifested by one or more of the following: spontaneous partial or complete wound dehiscence with erythema and/or pain, spontaneous PD, a wound abscess (based on palpitation findings of the surgeon and/or needle aspiration of purulence into palpable fluctuance, and/or ultrasound examination above the fascia), clinical or histological evidence of fasciitis or myonecrosis.

Other Outcomes

Measure	Description	Time Frame
Minimum Inhibitory Concentration (MIC) at 90%	In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MIC. MIC 90 is defined as the lowest concentration of study drug that inhibits the growth of 90% of aerobic microorganisms tested.	Surgery (Day 0) up to to 30 days post surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled to undergo elective colon and/or rectal surgical procedures involving open laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The principal incision must have a length of > 5 cm and < 35 cm in length. Eligible surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy, ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis, and abdominal perineal resection of the rectum.
Able to give informed consent.
If female, is non-pregnant (negative pregnancy test result at the Screening/Randomization Visit) and non-lactating.
If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth control and agrees to continue with this regimen over the study surveillance period:
- Oral, implantable, or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit
- Intrauterine device
- Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream)
- Not sexually-active. Agreement to be available for evaluation at the study site for scheduled visits.

Exclusion Criteria:

Hypersensitivity to porcine products.
History of known anti-myeloperoxidase autoantibodies (i.e., perinuclear anti-neutrophil cytoplasmic antibody [pANCA]), as well as participants with known idiopathic necrotizing glomerulonephritis and certain systemic vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels, Wegener's granulomatosis, and Churg-Strauss Syndrome]).
Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any antimicrobial-embedded suture to close the principal incision or any suture in the surgical field that has not been formally approved by the relevant local national regulatory authority.
Absolute contraindication to general anesthesia.
Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or sutures. (Note: If there can be assurances that the participant will not be exposed to these materials that cause hypersensitivity, alternatives will be allowed.)
History of keloid or hypertrophic scarring within or near an incision from a prior surgery.
Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor wound healing).
American Society of Anesthesiologists (ASA) Score > 3.
Undergoing emergency colorectal surgery such that standard bowel preparation and other standard preoperative precautions and assessments cannot be performed in time before the index-surgery.
The planned index-surgery involves removal or placement of mesh (either synthetic or biological) as part of closure in the principal incision or traversing any part of a pre-existing mesh (either synthetic or biological) in the principal incision.
There are clinical signs of overt infection necessitating systemic antibiotics via oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall, peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.
Preoperative severe neutropenia (total neutrophil count ≤500 X 109/L). (Note: Testing should be performed at the local laboratory.)
Receiving any oral or intravenous antibiotics within 24 hours prior to the index-surgery. (Note: It is permissible to administer conventional oral prophylactic antibiotics as bowel preparation up to the time of the index- surgical procedure, as well as intravenous or intramuscular prophylactic antibiotics just prior to the index-surgery as per the treating surgeon's standard of care.)
Preoperative evaluation that the intra-abdominal process might preclude full closure of the skin incision due to severe or morbid obesity (i.e., any mechanical reason that would prevent/preclude primary intent wound healing) at the principal incision.
History of major organ transplantation (e.g., lung, liver, or kidney), including bone marrow transplantation, or intent to perform major organ transplant as a concomitant surgery.
History of a complicated laparotomy within 30 days prior to planned index-surgery.
Planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery.
Likely preoperative urinary tract infection, as evident by: i) symptoms of upper urinary tract infection (e.g., fever and/or flank pain) or ii) symptoms of lower urinary tract infection (e.g., urinary frequency, dysuria, urgency, and/or suprapubic pain); accompanied by any one of the following: 1) bacteriuria of ≥104 bacteria/mL urine or 2) positive urine leucocyte esterase or positive nitrite urine dipstick tests. Also exclude any man under age 60 years who has both positive urine nitrite and leucocyte esterase dipstick tests - even if he is asymptomatic (unless he has predisposing factors for urinary tract infection - e.g., spinal cord injury). (Note: Testing should be performed at the local laboratory.)
Undergoing a significant concomitant surgical procedure (e.g., hysterectomy) or any mesh repair (either synthetic or biological mesh) as part of closure. The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, removal of Meckel's diverticulum, primary repair of small ventral hernia (i.e., <30 cm2), liver biopsy/wedge resection (but not liver resection).
Participants with a condition (e.g., recurrent urinary tract infections, nail infections, sinusitis, dental infections, vaginitis/vaginosis, or chronic bronchitis) requiring frequent or chronic administration of antimicrobials (received antibiotics/antimicrobials at least twice for ≥ 2 weeks during past 6 months).
Preoperative prothrombin time or international normalized ratio (INR) > 2 x upper limit of normal. (Note: Testing should be performed at the local laboratory.)
Postsurgical life expectancy ≤ 60 days (in the Investigator's or Sponsor's opinion).
Any participant in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iii) placement of a drain into the intraperitoneal space that emerges through the principal incision; and iv) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs.
Participant with severe Chronic obstructive pulmonary disease (COPD) that are likely to need > 24 hours postoperative ventilator support (e.g. participant on chronic or intermittent supplemental oxygen or an estimated forced expiratory volume in 1 second (FEV1) less than 50% of expected based on bedside spirometry).
If, in the opinion of Investigator, the potential participant would likely be unable to maintain adequate care of the principal incision post-operatively.
Anticipate that participant will not be available for study visits/ procedures or if in the opinion of Investigator there is concern that participant might not comply with study visits/procedures (e.g., due to ongoing illicit drug usage or alcohol abuse).
Lack of willingness to have personal study-related data collected, archived, or transmitted under a blinded condition to regulatory agencies.
Participation within 30 days before the start of this study in any experimental drug or device study; or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.

Name	Affiliation	Role
Peter O'Hanley, PhD, MD, MPH	Excited States, LLC	Study Director
Robert Martindale, MD, PhD	Oregon Health and Science University	Study Chair
Michael J Stamos, MD	University of California, Irvine	Principal Investigator
Jerrold H Levy, MD	Emory Healthcare	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Medical Center		Mobile	Alabama	36617	United States
University of Southern California

PubMed Identifier	Type	Citation	Retractions
	Result	Denys, G.A., O'Hanley P, Stephens, JT. E-101 Solution demonstrates antiviral properties against Herpes Simplex Virus, Human Immunodeficiency Virus, and Human Influenza A/H1N1 Virus. American Society for Microbiology, 110th General meeting, San Diego, CA (Abstract # C-2061). May 2010.
	Result	O'Hanley, P, Beausoleil C, O'Hanley K, Stephens, JT. E-101 Solution, a novel antiseptic intended for direct application within a surgical wound to prevent surgical site infection: Blinded, controlled Phase 1 skin irritation study in healthy volunteers. Annual Surgical Site Infection Meeting, Las Vegas, NV, May 2010.
	Result	O'Hanley P, O'Hanley K, Beausoleil C, Stephens JT. E-101 Solution (E-101), a Myeloperoxidase (MPO) Antiseptic for Prevention of Surgical Site Infections (SSI): Phase 1 Sensitization and Microbial Reduction in Healthy Adult Volunteers. Program and Abstracts of the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy, Boston, MA, October 2010.
	Result	Pillar, C, Denys GA, O'Hanley P, Stephens JT, Sahm D. E-101, a novel in class topical anti-infective, has potent activity against clinical isolates of important pathogens in Europe collected from 2008-2010. 21st ECCMID/27th ICC, Milan, Italy, May 2011.
	Result	Pillar C, Denys GA, O'Hanley P, Stephens JT, Sahm D. E-101, a novel in class topical anti-infective, maintains a high degree of potency in vitro against problematic resistant clinical pathogens (ESKAPE pathogens). 21st ECCMID/27th ICC, Milan, Italy, May 2011.

ID	Title	Description
FG000	E-101 Solution 300 GU/mL	Participants received 8 milliliter (mL) of E-101 Solution at porcine myeloperoxidase (pMPO) concentration of 300 guaiacol units per milliliter (GU/mL) applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants In Intent to Treat (ITT) Analysis Set With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving Principal Incision Within 30 Days After Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively

Superficial SSI: purulent drainage (PD) from superficial incision (SI), organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from principal incision (PI), or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on Clinical Infection Wound Scale (CIWS). Deep incisional SSI: PD from deep incision (DI) but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

ITT Analysis Set included all randomized participants in their assigned treatment group except those were found between randomization and before surgery to either meet exclusion criteria or not meet inclusion criteria, who withdrew consent or were treated at site 03-03 (participants were excluded because of a systematic problem in incisional SSI surveillance due to a lack of blinded assessors). Cumulative Treatment Incisional SSI was reported which included Superficial SSI and Deep SSI.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Units	Counts
Participants	OG000241 OG001225

Title

Denominators

Categories

Title	Measurements
	OG00053 OG00141

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.	0.39														Superiority

Primary

Number of Participants In Per-Protocol (PP) Analysis Set With Superficial and Deep Incisional SSI Involving Principal Incision Within 30 Days After the Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively

Superficial SSI: PD from SI, organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from PI, or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on CIWS. Deep incisional SSI: PD from DI but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

PP Analysis Set included all participants from ITT Analysis Set without any major protocol violations. Cumulative Treatment Incisional SSI was reported which included Superficial SSI and Deep SSI.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Mean Clinical Infection Wound Scale Score (CIWS)

CIWS was used postoperatively to evaluate the primary incisional wound for clinical evidence of infection. Score ranged from 0 (normal) - 5 (worst). 0: normal post-operative wound appearance, 1: wound erythema with pain extending ≥ 2 cm away from the primary incision, 2: spontaneous wound dehiscence with erythema and/or pain extending < 2 cm along primary incision, 3: spontaneous wound dehiscence with erythema and/or pain extending ≥ 2 cm along primary incision, 4: PD from the primary incision, 5: infection of primary incision involving deep incisional structures (muscle and/or fascia) manifested by one or more of the following: spontaneous partial or complete wound dehiscence with erythema and/or pain, spontaneous PD, a wound abscess (based on palpitation findings of the surgeon and/or needle aspiration of purulence into palpable fluctuance, and/or ultrasound examination above the fascia), clinical or histological evidence of fasciitis or myonecrosis.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Objectively Determined Incisional Surgical Site Infections (SSI)

Number of participants with objectively determined SSI (defined as participants with PD, wound abscess, or positive microbial culture from one or more incisional samples) are reported.

Participants in the ITT Analysis Set were analyzed.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving the Principal Incision (PI) Within 30 Days After the Index-surgery as Determined by Blinded Assessors 14 Days Post-operatively

Superficial SSI: PD from SI, organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from PI, or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but CIWS. Deep incisional SSI: PD from DI but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by a surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

Participants in the ITT Analysis Set were analyzed. Cumulative Treatment Incisional SSI was reported which included Superficial SSI and Deep SSI.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 14 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Mobility Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The mobility score questionnaire asked the participants to rate if they had problems walking around on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline mobility scale score was presented.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Self-Care Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The self-care questionnaire asked the participants to rate if they had any problems with self-care on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline self-care scale score was presented.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Usual Activity Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The usual activity questionnaire asked the participants to rate if they had any problems with usual activities on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline usual activity scale score was presented.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Pain/Discomfort Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The pain/discomfort score questionnaire asked the participants to rate if they had any pain or discomfort on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline pain/discomfort scale score was presented.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Anxiety/Depression Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The anxiety/depression questionnaire asked the participants to rate if they had any anxiety or depression on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline anxiety/depression scale score was presented.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Worst Post-Baseline Health State Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

The EQ-5D health state scale is a visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better state of health. Participants were asked to rate their health state from 0 to 100. The mean worst post-baseline health state score was reported.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

score on a scale

Day 0 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Re-Hospitalization

Number of participants who had re-hospitalization for SSI were reported.

Participants in the ITT Analysis Set were analyzed.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Units

Secondary

Number of Participants With Clinical Wound Healing Score (CWHS) as Assessed by Blinded Assessors

CWHS was assessed by blind assessors as 0= normal, intact incision without any spontaneous wound dehiscence; 1= spontaneous wound dehiscence that extends < 2 cm along the principal incision in the absence of erythema and/or pain 2= spontaneous wound dehiscence that extends ≥ 2 cm along the principal incision in the absence of erythema and/or pain. Number of participants with various levels of CWHS scores were reported.

Participants in the Safety Analysis Set (all participants randomized to treatment and exposed to any quantity of study drug) with available data were analyzed.

Posted

Count of Participants

Participants

Day 3 up to Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Unexpected Adverse Reactions (UARs)

AE: Any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. ADR: All noxious and unintended responses to a medicinal product related to any dose. SAE: AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: an event that was not present prior to administration of study medication, or, if present prior to administration of study medication, increases in intensity after administration of study medication during study. SUSAR: all suspected adverse reactions (ARs) related to an investigational medicinal product (IMP) that occurred in study, and that were both unexpected and serious. UAR: an ARs, nature and severity of which was not consistent with the current medicinal product information.

Participants in the Safety Analysis Set were analyzed.

Posted

Count of Participants

Participants

From first dose up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Clinically Significant Laboratory Findings

Number of participants with clinically significant laboratory findings were reported. The clinical significance was decided by the investigator.

Participants in the Safety Analysis Set were analyzed.

Posted

Count of Participants

Participants

From first dose up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Clinically Significant Physical Examination Findings

Number of participants with clinically significant physical examination findings were reported. The clinical significance was decided by the investigator.

Participants in the Safety Analysis Set were analyzed.

Posted

Count of Participants

Participants

From first dose up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants by Wound Pain Assessment Scores

Number of participants with wound pain assessment scores were assessed on a categorical scale ranging from 0 to 10, where 0 is no pain and 10 is unimaginable, unspeakable pain. Higher number on the scale represents worst possible pain.

Participants in the Safety Analysis Set with available date were analyzed.

Posted

Count of Participants

Participants

Surgery (Day 0) up to 30 days post-surgery

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With pANCA Immunoglobulin G (IgG) Antibody, Serum Anti-glucose Oxidase (GO) IgG,M,A, pMPO IgG,M,A, Serum GO Neutralization, Serum pMPO Neutralization Antibody

Antibody assessment was done using enzyme-linked immunosorbent assay (ELISA) test.

Participants in the Antibody Safety Set (all participants who were randomized to and exposed to any quantity of study drug with sufficient data to determine antibody results) with available data were analyzed.

Posted

Count of Participants

Participants

Day 14 and Day 30

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With pANCA IgG Anti-body, Serum Anti-GO IgG,M,A, pMPO IgG,M,A, Serum Neutralization GO, Serum pMPO Neutralization Antibody

Antibody assessment was done using ELISA test.

Participants in the Antibody Safety Set with available data were analyzed.

Posted

Count of Participants

Participants

Month 3 and Month 6

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Secondary

Number of Participants With Serum pANCA and pMPO Antibody Response

Participants in the Safety Analysis Set were analyzed.

Posted

Count of Participants

Participants

Day 30, Month 3 and Month 6

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
OG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Units	Counts
Participants

Other Pre-specified

Minimum Inhibitory Concentration (MIC) at 90%

In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MIC. MIC 90 is defined as the lowest concentration of study drug that inhibits the growth of 90% of aerobic microorganisms tested.

Per Protocol Analysis Set; only participant samples with isolated pathogens were included in the analysis

Posted

Number

mg pMPO/mL

Surgery (Day 0) up to to 30 days post surgery

isolates

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Units	Counts
Participants	OG000

Other Pre-specified

Minimum Bactericidal Concentration (MBC) at 90%

In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MBC. MBC 90 is defined as the lowest concentration of study drug required to kill greater than or equal to 99.9% (bactericidal) of the aerobic microorganisms tested.

Per Protocol Analysis Set; only participant samples with isolated pathogens were included in the analysis

Posted

Number

mg pMPO/mL

Surgery (Day 0) up to to 30 days post surgery

isolates

ID	Title	Description
OG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Diabetes insipidus	Endocrine disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Anal fistula	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected248 at risk EG0012 affected234 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected234 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected248 at risk EG0010 affected234 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected248 at risk EG0014 affected234 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected234 at risk
Fat necrosis	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Fatigue	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Pyrexia	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Secretion discharge	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Abdominal abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected248 at risk EG0013 affected234 at risk
Abdominal infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Abdominal wall abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Bacteraemia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Cellulitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected234 at risk
Clostridium difficile infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Empyema	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Gastroenteritis viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Graft infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Pelvic infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected234 at risk
Pericolic abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Peritonitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0011 affected234 at risk
Pneumonia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0015 affected234 at risk
Post procedural sepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Sepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0004 affected248 at risk EG0012 affected234 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Thrombophlebitis septic	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected248 at risk EG0010 affected234 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0007 affected248 at risk EG0019 affected234 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0012 affected234 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected248 at risk EG0014 affected234 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Ureteric injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Blood creatinine increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0005 affected248 at risk EG0013 affected234 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0012 affected234 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected248 at risk EG0010 affected234 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Abscess drainage	Surgical and medical procedures	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected248 at risk EG0011 affected234 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00027 affected248 at risk EG00129 affected234 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00020 affected248 at risk EG00128 affected234 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00017 affected248 at risk EG00114 affected234 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00014 affected248 at risk EG00114 affected234 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00015 affected248 at risk EG00111 affected234 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00098 affected248 at risk EG00193 affected234 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00034 affected248 at risk EG00140 affected234 at risk
Pyrexia	General disorders	MedDRA Version 16.0	Systematic Assessment	EG00038 affected248 at risk EG00135 affected234 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG00013 affected248 at risk EG0018 affected234 at risk
Blood magnesium decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00011 affected248 at risk EG00118 affected234 at risk
Blood phosphorus decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00012 affected248 at risk EG00119 affected234 at risk
Haemoglobin decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00012 affected248 at risk EG00119 affected234 at risk
Oxygen saturation decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00013 affected248 at risk EG00117 affected234 at risk
Urine output decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0005 affected248 at risk EG00117 affected234 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00031 affected248 at risk EG00130 affected234 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00022 affected248 at risk EG00124 affected234 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00019 affected248 at risk EG00111 affected234 at risk
Insomnia	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG00017 affected248 at risk EG00120 affected234 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected248 at risk EG00116 affected234 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG00020 affected248 at risk EG00116 affected234 at risk
Hypotension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG00022 affected248 at risk EG00119 affected234 at risk

ID	Term
D014946	Wound Infection
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
BG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	E-101 Solution 300 GU/mL	Participants received 8 mL of E-101 Solution at pMPO concentration of 300 GU/mL applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.	2	248	57	248	180	248
EG001	Placebo (Saline Solution)	Participants received placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application occurred just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application occurred just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.	2	234	56	234	174	234