Viewing Study NCT01083472



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Study NCT ID: NCT01083472
Status: TERMINATED
Last Update Posted: 2013-11-19
First Post: 2010-03-08

Brief Title: Repair of Challenging Abdominal Wall Defects StratticeTM TM in Abdominal Wall Repair StAR
Sponsor: LifeCell
Organization: LifeCell

Study Overview

Official Title: A Multicenter Prospective Single-Blind Randomized Controlled Study of the Repair of Challenging Abdominal Wall Defects StratticeTM TM in Abdominal Wall Repair
Status: TERMINATED
Status Verified Date: 2013-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: StAR
Brief Summary: The objective of this study is to compare the incidence of post-repair wound related complications including hernia occurrencerecurrence between challenging abdominal wall defects repaired with StratticeTM Reconstructive Tissue Matrix TM and those managed by standard repair It is hypothesized that the use of StratticeTM 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 StratticeTM 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 ie 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 fasciaviscera 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 interventionmedical 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 StratticeTM TM reinforcement of repair or standard of care repair ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None