Phase 2 N=40 Randomized Single-blind Treatment

Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Seroma · Hematoma

Bottom Line

View on ClinicalTrials.gov: NCT01112735 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jul 2018

Primary outcome: Primary: Total Drainage Volume Collected Until Drain Removal — 407.45; 595.90 mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) (Biological); Standard of care (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baxter Healthcare Corporation
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Drainage Volume Collected Until Drain Removal	407.45; 595.90	—
SECONDARY Occurrence of Seroma	8; 5	—
SECONDARY Occurrence of Hematoma	0; 0	—
SECONDARY Time to Drain Removal	6.8; 9.55	—
SECONDARY Number of Fluid Aspiration for Seromas	5; 3.2	0.5621
SECONDARY Total Volume of Fluid Aspirations for Seromas	226.13; 152.2	0.3595
SECONDARY Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus	0.92; 0.89; 0.55; 0.73; 0.78; 0.54	0.9417
SECONDARY Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus	1.81; 1.78; 1.47; 1.02; 1.28; 0.49	0.9699
SECONDARY Summary of Pain Assessment by Visit	3.68; 4; 2.7; 2.8; 1.7; 1.7	—
SECONDARY Summary of Numbness Assessment by Visit	5.16; 6.30; 5.50; 4.95; 4.45; 4.35	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01112735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.