Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Seroma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112735
• Other study ID #: 550902
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2018
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Seroma

Intervention

Biological:
• 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.

Procedure:
• Standard of care
Standard of care

Locations

Country	Name	City	State
United States	Places Plastic Surgery	Atlanta	Georgia
United States	Mei Li Surgery Center	Beverly Hills	California
United States	The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates	Chicago	Illinois
United States	UT Southwestern Medical Center, Department of Plastic Surgery	Dallas	Texas
United States	Center for Plastic Surgery and Skin Care	Fort Lauderdale	Florida
United States	Miami Plastic Surgery	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 0 (Surgery Day) to Day 90
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.	Day 0 (Surgery Day) to Day 90
Secondary	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.	Day 0 (Surgery Day) to Day 90
Secondary	Time to Drain Removal	The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.	Day 0 (Surgery Day) up to Day 90
Secondary	Number of Fluid Aspiration for Seromas	Number of interventions recorded.	Day 0 (Surgery Day) to Day 90
Secondary	Total Volume of Fluid Aspirations for Seromas	Volume of fluid recovered was recorded.	Day 0 (Surgery Day) to Day 90
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.	Days 0 (Baseline), 3, 7, 14, 28, 60, 90
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.	Days 0 (Baseline), 3, 7, 14, 28, 60, 90
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.	Day 3, 7, 14, 28, 60, 90
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.	Day 3, 7, 14, 28, 60, 90