NCT01083472

Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)

A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: LifeCell · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

Detailed description

This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. "crossed over") or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect \[dehiscence, hernia repair or open abdomen\], morbidity \[POSSUM score\] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups. The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality. Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.

Conditions

• Hernia
• Surgical Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	Strattice(TM) Reconstructive Tissue Matrix	Strattice(TM) TM will be used to support the repair of abdominal wall defect
PROCEDURE	Suture/suture with absorbable mesh	Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-03-09
• Last updated: 2013-11-19
• Results posted: 2013-11-19

Locations

29 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom