Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

NCT01112735 | Completed Phase 2 Results

• 1 other identifier: 550902
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Seroma; Hematoma

Keywords

Abdominoplasty; Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation

Outcome Measures

Primary Outcomes (1)

• 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 (9)

• Occurrence of Seroma

  Day 0 (Surgery Day) to Day 90

• Occurrence of Hematoma

  Day 0 (Surgery Day) to Day 90

• Time to Drain Removal

  Day 0 (Surgery Day) up to Day 90

• Number of Fluid Aspiration for Seromas

  Day 0 (Surgery Day) to Day 90

• Total Volume of Fluid Aspirations for Seromas

  Day 0 (Surgery Day) to Day 90

Study Arms (2)

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

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.

Also known as: ARTISS

ARTISS

Standard of care PROCEDURE

Standard of care

Standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (6)

Mei Li Surgery Center

Beverly Hills, California, 90210, United States

Location

Center for Plastic Surgery and Skin Care

Fort Lauderdale, Florida, 33308, United States

Location

Miami Plastic Surgery

Miami, Florida, 33176, United States

Location

Places Plastic Surgery

Atlanta, Georgia, 30327, United States

Location

The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates

Chicago, Illinois, 60654, United States

Location

UT Southwestern Medical Center, Department of Plastic Surgery

Dallas, Texas, 75390-9132, United States

Location

MeSH Terms

Conditions

Seroma; Hematoma

Interventions

Low Density Lipoprotein Receptor-Related Protein-1; Standard of Care

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

LDL-Receptor Related Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, LDL; Receptors, Lipoprotein; Receptors, Cell Surface; Membrane Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Clinical Trials Disclosure Group
• Organization: Baxter Healthcare Corporation

Global_CORP_ClinicalTrialsDisclosure@baxter.com

734-646-8214

Study Officials

• Steve Z Abrams, MD, MBA

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 6, 2018
• Results First Posted: July 6, 2018

Record last verified: 2018-06

Locations

US (6)