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Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care (SOC). The other half will receive the Standard of Care treatment.
Following the surgery subjects will be followed up for additional 5 visits, at least half are in line with the routine practice of surgery Follow-Ups.
Visits will include patient safety and wound assessments.
D-PLEX is a new formulation of extended controlled release of Doxycycline in the applied area for about 30 days. This study is aimed to assess the safety and efficacy of D-PLEX in prevention of post abdominal surgery incisional infection.
Eligible and willing subjects will be randomly divided, in a single-blinded manner into 2 study arms D-PLEX with SOC or SOC alone. D-PLEX will be applied during the surgery at the final stage of incision closure. All patients will be followed up for additional 5 visits over 2 months, for safety and incisional wound assessment. This will include blood tests for hematology, chemistry and pharmacokinetics (PK, for some only) as well as physicians assessment of the incisional wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SoC) | Other | SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. |
|
| D-PLEX + SoC | Experimental | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-PLEX | Drug | D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). |
| Measure | Description | Time Frame |
|---|---|---|
| The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery | The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery | 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Average ASEPSIS Assessment Score (for Parameters Additional Treatment, Serous Discharge, Erythema, Purulent Exudate, Separation of Deep Tissue, Isolation of Bacteria, Stay Duration as Inpatient) During 30 Days Post-surgery. | ASEPSIS is acronym of wound assessment and treatment parameters (described in the title), which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection. Each parameter will be evaluated and numerically scored. Some (Serous discharge & Erythema) will be marked between 0 - 5 and others (Purulent exudate & Separation of deep tissue) are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound. Other parameters (Additional antibiotic treatment, a requirement for pus drainage, isolation of bacteria & stay duration as an inpatient) are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others. The final score can be in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | The number and proportion of subjects who experienced Surgical site infection (SSI) within 30 days | 30 days post-surgery |
| Incidence of Superficial Surgical Site Infection (SSSI) During 30 Days Post-surgery |
Inclusion Criteria:
Exclusion Criteria:
Subjects scheduled for abdominal surgery which is classified as emergency.
Subjects with any preoperative active infection that is currently being treated with antibiotics.
Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrollment other than prophylaxis or antibiotic for the treatment of the disease for which the surgery is indicated.
Subjects undergoing concomitant additional procedures other than colon resection surgery (e.g., hyper-thermic intraperitoneal chemotherapy, liver resection, etc.).
Female sterilization surgery (e.g., salpingo-oophorectomy, hysterectomy, etc.), involvement of a small bowel procedure, or cholecystectomy may be allowed, pending an advanced consultation and approval from the sponsor.
Subject received chemotherapy within the past 4 weeks of surgery, or radiation for colorectal cancer to the abdominal area, prior to the planned abdominal surgery (neo-adjuvant treatment).
Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
Subjects with known hypersensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX excipients.
Subjects with known allergies to more than 3 substances (as determined from allergy questionnaire at screening).
Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intravenous steroids/intramuscular epinephrine or in the opinion of the investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions.
Subjects with uncontrolled asthma (GINA III-IV).
Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
Subjects with chronic urticaria.
Subjects diagnosed with TIA/CVA/ACS within the past 1 year prior to randomization.
Subjects that have undergone any prior abdominal surgery and current planned surgery involves re-opening the scar of the prior abdominal surgery.
Any subject with an active malignancy or malignancy that has not been in complete remission for at least 5 years. Excluding:
Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study (e.g., non-GI active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, uncompensated cirrhosis, active upper GI tract ulceration).
Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
Chronic alcohol or drug abuse.
Pregnant or breast-feeding women or women of childbearing age who refuse or are prohibited from using an effective contraceptive method of birth control (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) throughout study participation including the safety follow-up period.
Subjects that received any investigational drug within 30 days or 5½ half-lives of enrollment in the study (whichever is longer).
Subjects participating in any other interventional studies.
Any subject who, in the opinion of the investigator, is not eligible to participate in the study and/or comply with protocol requirements (e.g., due to a cognitive or medical condition).
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| Name | Affiliation | Role |
|---|---|---|
| Shmuel Sharoni, MD | Medical Director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson MC | Holon | Israel | ||||
| Meir MC |
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Subjects who met the eligibility requirements were randomized to either the investigational arm (SOC + D-PLEX) or the control arm (SOC only) in a 1:1 ratio. Subjects were randomized through an interactive web randomization system (IWRS) integrated with the electronic Case Report Form (eCRF), based on the subject's information collected during the screening period and details of the planned surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SoC) | SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2018 | Jan 6, 2026 |
Not provided
Males and females, >18 years old, undergoing scheduled abdominal colon surgery involving resection and anastomosis or a stoma, who meet the inclusion criteria and none of the exclusion criteria and provide signed informed consent will be enrolled in the study.
Subjects will be randomized to either the investigational arm (SOC + D-PLEX) or to the control arm (SOC only) in a 1:1 ratio.
Subjects will be blinded to the study arm.
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Subject will be blinded to the treatment arm assignment. Physicians which were not part of the team in the surgery room, or from the hospital's infectious diseases dept. will remain blinded to the study arm, and will be those assessing the incisional wound for the study primary endpoint at each follow-up visit post the index surgery.
On top, for each suspicion of infection, an external, independent and blinded adjudication committee will be the one making the final decision whether an infection occured or not.
| Standard of Care (SoC) | Other | Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure |
|
| 30 days post surgery |
| Mortality Rate Within 30 Days Post Abdominal Surgery | Death from any reason within 30 days post abdominal surgery | 30 days post surgery |
The number and proportion of subjects who experienced at least one SSSI within 30 days post abdominal surgery were presented by treatment.
| 30 days post surgery |
| Incidence of Deep Surgical Site Infection (DSSI) During 30 Days Post-surgery | The number and proportion of subjects who experienced at least one DSSI within 30 days post abdominal surgery were presented by treatment. | 30 days post surgery |
| Mortality Rate Within 60 Days Post Abdominal Surgery | Death from any reason within 60 days post abdominal surgery | During 60 days of study participation |
| Number of Overall Hospitalization Days Post Surgery | Number of hospitalization days after surgery and until discharge. Will include prolongation of primary hospitalization compared to the average of the rest of the recruited patients and re-admission due to infection | During 60 days of study participation |
| Subject Hospitalization Due to SSI | The number and proportion of subjects hospitalized due to SSI within 30 days post-surgery | 30 days post-surgery |
| Susceptibility to Doxycycline | Resistance to Doxycycline for any organisms recovered from an abdominal surgery incisional Infection site will be done using a central lab. Any organism which will grow (if), will be further tested for Doxycycline susceptibility. The number of participants who have bacterial growth analyzed was summarized by treatment group. | 30 days post surgery |
| Number of Re-admissions Due to Surgical Site Infection | The number and proportion of subjects with hospital re-admission due to SSI. | During 30 days of study participation |
| Number of Antibiotic Treatment Days Post Surgery | The number of antibiotic treatment days due to SSI. | 60 days post surgery |
| Subjects Receiving Antibiotics Due to SSI | The number and proportion of subjects who received antibiotics due to SSI | 60 days post-surgery |
| Time to Surgical Site Infection | Number of days between surgery and a confirmed incisional surgery infection | 30 days post surgery |
| Kfar Saba |
| Israel |
| Rabin MC, Campus Beilinson | Petah Tikva | Israel |
| Sheba MC, Tel-Hashomer | Ramat Gan | Israel |
| Kaplan MC | Rehovot | Israel |
| Assuta Ramat-HaHayal | Tel Aviv | Israel |
| Tel-Aviv Sourasky MC | Tel Aviv | Israel |
| Assaf-Harofeh MC | Zrifin | Israel |
| FG001 | D-PLEX + SoC | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D_PLEX: D_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure |
| Number of Subjects in the ITT Population | In this analysis set, treatment was assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received |
|
| Actual Number of Subjects Treated in Each Treatment Group (Safety Population) | In this population, treatment was assigned based upon the treatment subjects actually received, regardless of the treatment to which they were randomized. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
One subject was excluded from the ITT population (SoC arm) as was not undergo abdominal surgery and had no abdominal incision to evaluate.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SoC) | SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: According to each participating center standard practice for this type of procedure |
| BG001 | D-PLEX + SoC | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: According to each participating center standard practice for this type of procedure |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data is based on the safety population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Demographic data is based on safety population only | Count of Participants | Participants |
| |||||||||||||||
| BMI | Subjects demographics and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Height | Subjects demographic and other baseline characteristics were analyzed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm | Mean | Standard Deviation | cm |
| ||||||||||||||
| Weight | Subjects demographic other baseline characteristics were analysed for the Safety population that includes 100 subjects in the SoC arm and 99 subjects in the D-PLEX + SOC arm | Mean | Standard Deviation | kg |
|
| 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 | The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery | The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery | Intent to Treat (ITT) population. | Posted | Count of Participants | Participants | 30 days post surgery |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average ASEPSIS Assessment Score (for Parameters Additional Treatment, Serous Discharge, Erythema, Purulent Exudate, Separation of Deep Tissue, Isolation of Bacteria, Stay Duration as Inpatient) During 30 Days Post-surgery. | ASEPSIS is acronym of wound assessment and treatment parameters (described in the title), which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection. Each parameter will be evaluated and numerically scored. Some (Serous discharge & Erythema) will be marked between 0 - 5 and others (Purulent exudate & Separation of deep tissue) are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound. Other parameters (Additional antibiotic treatment, a requirement for pus drainage, isolation of bacteria & stay duration as an inpatient) are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others. The final score can be in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection. | ITT population | Posted | Mean | Standard Deviation | score on a scale | 30 days post surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality Rate Within 30 Days Post Abdominal Surgery | Death from any reason within 30 days post abdominal surgery | ITT population | Posted | Count of Participants | Participants | 30 days post surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Infection Rate | The number and proportion of subjects who experienced Surgical site infection (SSI) within 30 days | ITT population | Posted | Count of Participants | Participants | 30 days post-surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Superficial Surgical Site Infection (SSSI) During 30 Days Post-surgery | The number and proportion of subjects who experienced at least one SSSI within 30 days post abdominal surgery were presented by treatment. | ITT population | Posted | Count of Participants | Participants | 30 days post surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Deep Surgical Site Infection (DSSI) During 30 Days Post-surgery | The number and proportion of subjects who experienced at least one DSSI within 30 days post abdominal surgery were presented by treatment. | ITT population | Posted | Count of Participants | Participants | 30 days post surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mortality Rate Within 60 Days Post Abdominal Surgery | Death from any reason within 60 days post abdominal surgery | ITT population | Posted | Count of Participants | Participants | During 60 days of study participation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Overall Hospitalization Days Post Surgery | Number of hospitalization days after surgery and until discharge. Will include prolongation of primary hospitalization compared to the average of the rest of the recruited patients and re-admission due to infection | ITT population | Posted | Mean | Standard Deviation | Days | During 60 days of study participation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject Hospitalization Due to SSI | The number and proportion of subjects hospitalized due to SSI within 30 days post-surgery | ITT population | Posted | Count of Participants | Participants | 30 days post-surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Susceptibility to Doxycycline | Resistance to Doxycycline for any organisms recovered from an abdominal surgery incisional Infection site will be done using a central lab. Any organism which will grow (if), will be further tested for Doxycycline susceptibility. The number of participants who have bacterial growth analyzed was summarized by treatment group. | ITT population | Posted | Number | participants | 30 days post surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Re-admissions Due to Surgical Site Infection | The number and proportion of subjects with hospital re-admission due to SSI. | ITT population | Posted | Count of Participants | Participants | During 30 days of study participation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Antibiotic Treatment Days Post Surgery | The number of antibiotic treatment days due to SSI. | ITT population | Posted | Mean | Standard Deviation | Days | 60 days post surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subjects Receiving Antibiotics Due to SSI | The number and proportion of subjects who received antibiotics due to SSI | The number of ITT population subjects who experienced at least one adjudicated SSI | Posted | Count of Participants | Participants | 60 days post-surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Surgical Site Infection | Number of days between surgery and a confirmed incisional surgery infection | The number of ITT population subjects who experienced at least one adjudicated SSI | Posted | Mean | Standard Deviation | Days | 30 days post surgery |
|
|
2 month
All-Cause Mortality were assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SoC) | SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure | 5 | 100 | 20 | 100 | 52 | 100 |
| EG001 | D-PLEX + SoC | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D-PLEX: D-PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure | 0 | 101 | 16 | 99 | 50 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Internal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Ureteric injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vesicocutaneous fistula | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eyal Shoshani, VP Clinical Affaies | PolyPid | +972-74-719-5700 | 138 | eyal.s@polypid.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2019 | Jan 6, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
|
|
|
|
|
| OG001 | D-PLEX + SoC | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment D_PLEX: D_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis). Standard of Care (SoC): Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure |
|
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Counts |
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| Participants |
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