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Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Primary Purpose

Seroma, Hematoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Standard of care
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seroma focused on measuring Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mei Li Surgery Center
  • Center for Plastic Surgery and Skin Care
  • Miami Plastic Surgery
  • Places Plastic Surgery
  • The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
  • UT Southwestern Medical Center, Department of Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ARTISS

Standard of care

Arm Description

ARTISS will be used as an adjuvant to standard of care.

Standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Occurrence of Hematoma
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 hematoma. A hematoma is a collection of blood outside of a blood vessel.
Time to Drain Removal
The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.
Number of Fluid Aspiration for Seromas
Number of interventions recorded.
Total Volume of Fluid Aspirations for Seromas
Volume of fluid recovered was recorded.
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.
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.
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.
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.

Full Information

First Posted
April 27, 2010
Last Updated
June 4, 2018
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01112735
Brief Title
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Official Title
A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma, Hematoma
Keywords
Abdominoplasty, Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARTISS
Arm Type
Experimental
Arm Description
ARTISS will be used as an adjuvant to standard of care.
Arm Title
Standard of care
Arm Type
Other
Arm Description
Standard of care
Intervention Type
Biological
Intervention Name(s)
FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Other Intervention Name(s)
ARTISS
Intervention Description
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Total Drainage Volume Collected Until Drain Removal
Description
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.
Time Frame
Day 0 (Surgery Day) to Day 90
Secondary Outcome Measure Information:
Title
Occurrence of Seroma
Description
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.
Time Frame
Day 0 (Surgery Day) to Day 90
Title
Occurrence of Hematoma
Description
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 hematoma. A hematoma is a collection of blood outside of a blood vessel.
Time Frame
Day 0 (Surgery Day) to Day 90
Title
Time to Drain Removal
Description
The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.
Time Frame
Day 0 (Surgery Day) up to Day 90
Title
Number of Fluid Aspiration for Seromas
Description
Number of interventions recorded.
Time Frame
Day 0 (Surgery Day) to Day 90
Title
Total Volume of Fluid Aspirations for Seromas
Description
Volume of fluid recovered was recorded.
Time Frame
Day 0 (Surgery Day) to Day 90
Title
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Description
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.
Time Frame
Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Title
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Description
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.
Time Frame
Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Title
Summary of Pain Assessment by Visit
Description
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.
Time Frame
Day 3, 7, 14, 28, 60, 90
Title
Summary of Numbness Assessment by Visit
Description
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.
Time Frame
Day 3, 7, 14, 28, 60, 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Z Abrams, MD, MBA
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Mei Li Surgery Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Center for Plastic Surgery and Skin Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Miami Plastic Surgery
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Places Plastic Surgery
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
UT Southwestern Medical Center, Department of Plastic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9132
Country
United States

12. IPD Sharing Statement

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Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

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