At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
Strattice Reconstructive Matrix +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies
In Brief
A Phase 4 clinical trial evaluating Strattice Reconstructive Matrix and Standard ostomy creation for Parastomal Hernia. Completed, enrolled 120 participants across 23 sites.
Detailed Summary
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParastomal Hernia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartDec 2008
Primary CompletionFeb 2012
Study CompletionJul 2012
TodayJul 2026
First PostedOct 13, 2008
Enrollment StartDec 1, 2008
Primary CompletionFeb 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.7 years ago
Interventions
Strattice Reconstructive Matrixdevice
Strattice will be placed as a fascial inlay to support stoma sites
Standard ostomy creationother
Ostomy will be created as routinely performed