Efficacy and Safety of ARTISS for Flap Adherence in Abdom... | NCT01112735

NCT01112735

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARTISS	Experimental	ARTISS will be used as an adjuvant to standard of care.	Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Standard of care	Other	Standard of care	Procedure: Standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)	Biological	Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Drainage Volume Collected Until Drain Removal	Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.	Day 0 (Surgery Day) to Day 90

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of Seroma	The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 to 75 years of age at the time of screening
Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed)
If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel)
Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

Subject is obese (body mass index [BMI] > 30 before surgery)
Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery)
Subject has a history of active smoking within the previous 12 months
Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy
Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted
Subject is planned for other "body lifting" procedures (eg to the arms, legs, back etc.)
Subject is planned for combined abdominoplasty with other cosmetic procedures including liposuction (restricted liposuction of the waist line and the lower back is allowed, as long as the integrity of the surgical spaces is maintained)
Subject has an active or chronic skin disorder, history or evidence of keloid formation, or hypertrophic scarring
Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome) requiring prescription medications
Subject has a known abdominal hernia that requires mesh fixation
Subject has a documented hiatal hernia or acid reflux disease
Subjects with congenital or acquired immunodeficiency disorders
Subject has uncontrolled diabetes mellitus (HbA1c > 7.0)
Subject has a history of cardio-vascular disease including uncontrolled hypertension (> 140/90 mm Hg)
Subject has a clinically diagnosed psychiatric disorder (including obsessive compulsive disorders)
Subject has a known (documented) bleeding or coagulation disorder including history of thromboembolic events
Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
Subject is receiving active treatment for a malignancy
Subject has a connective tissue disorder
Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Subject has a known sensitivity to fibrin sealants
Subject is a friend, employee, or relative of the investigator or other study personnel

Contacts/Locations Module

Name	Affiliation	Role
Steve Z Abrams, MD, MBA	Baxter Healthcare Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mei Li Surgery Center		Beverly Hills	California	90210	United States
Center for Plastic Surgery and Skin Care

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
BG001	Standard of Care	Standard of care
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00120 BG00240

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00040.90± 7.89 BG00145.60± 10.32 BG00243.25± 9.38

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG00119 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Total Drainage Volume Collected Until Drain Removal

Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.

Full Analysis Set (FAS) consists of all subjects who were randomized (ie, the investigator opened the randomization envelope) and treated and who had an available assessment for the primary efficacy endpoint.

Posted

Mean

Standard Deviation

Day 0 (Surgery Day) to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG000407.45± 470.36 OG001595.90± 519.46

Secondary

Occurrence of Seroma

The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.

FAS

Posted

Number

Events

Day 0 (Surgery Day) to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts

Secondary

Occurrence of Hematoma

FAS

Posted

Number

Events

Day 0 (Surgery Day) to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants

Secondary

Time to Drain Removal

The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.

FAS

Posted

Mean

Standard Deviation

Days

Day 0 (Surgery Day) up to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants	OG000

Secondary

Number of Fluid Aspiration for Seromas

Number of interventions recorded.

FAS

Posted

Mean

Standard Deviation

Interventions

Day 0 (Surgery Day) to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants	OG000

Secondary

Total Volume of Fluid Aspirations for Seromas

Volume of fluid recovered was recorded.

FAS

Posted

Mean

Standard Deviation

Day 0 (Surgery Day) to Day 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus

Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand & Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO:

ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.

FAS

Posted

Mean

Standard Deviation

Units on a Scale

Days 0 (Baseline), 3, 7, 14, 28, 60, 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.

Secondary

Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus

Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.

FAS

Posted

Mean

Standard Deviation

Score on a Scale

Days 0 (Baseline), 3, 7, 14, 28, 60, 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Secondary

Summary of Pain Assessment by Visit

Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 [no pain] to 10 [worst possible pain]) the patient experienced at the site of surgery at the time of the visit.

FAS

Posted

Mean

Standard Deviation

Score on a Scale

Day 3, 7, 14, 28, 60, 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants

Secondary

Summary of Numbness Assessment by Visit

Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 [no numbness] to 10 [complete numbness]) that the patient experienced at the time of the visit.

FAS

Posted

Mean

Standard Deviation

Score on a Scale

Day 3, 7, 14, 28, 60, 90

ID	Title	Description
OG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. ARTISS, also known as "FS VH S/D 4 s-apr" is a Fibrin Sealant Vapor Heated Solvent/Detergent Treated, and is a double virus inactivated 2-component fibrin sealant made from pooled human plasma. The dosage form is spray (aerosolized sealant) in a 10mL kit, and frequency was once (1 layer) applied at a dosing volume of between 0.02mL/cm2 and 0.04 mL/cm2 onto the fascia or the wound bed. The fibrin sealant matrix is biodegradable and disappears over a 2-3 week period.
OG001	Standard of Care	Standard of care

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ARTISS	ARTISS will be used as an adjuvant to standard of care. FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.	0	20	1	20	10	20
EG001	Standard of Care	Standard of care Standard of care: Standard of care	0	20	0	20	7	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypertension	Vascular disorders		Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected20 at risk EG0010 events0 affected20 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Incision Site Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk
Abdominal Abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk
Urinary Tract Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0009 events8 affected20 at risk EG0016 events5 affected20 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Staphylococcus Test Positive	Investigations	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Pruritus Generalized	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk
Incision Site Complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected20 at risk

ID	Term
D049291	Seroma
D006406	Hematoma

ID	Term
D026503	Low Density Lipoprotein Receptor-Related Protein-1
D059039	Standard of Care

Ancestor Terms

ID	Term
D026502	LDL-Receptor Related Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011973	Receptors, LDL
D018110	Receptors, Lipoprotein
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006470	Hemorrhage