MedTrace Logo

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

NCT01083472 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-11-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Hernia
  • Surgical Wound Dehiscence

Interventions

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

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Angus JM Watson · Raigmore Hospital, Inverness Scotland, National Health Service, UK

  • Berndt Reith · Klinikum Konstanz, Konstanz Germany

  • Johannes Jeekel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083472 on ClinicalTrials.gov