Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction - A Randomized Controlled Trial

Who is this study for? Adult patients undergoing an abdominal wall reconstruction
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

To date, there have been no prospective randomized controlled trials that compare various biologic mesh materials in the context of abdominal wall reconstruction. As a result, this proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a randomized manner. Although there are significant differences between these mesh products with regard to procurement, tissue processing and cost, clinical controlled trials are needed to compare their performance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The study population will consist of adult patients, 18 years or older, undergoing an abdominal wall reconstruction. Prior to selection, at least 2 surgeons involved in the trial must agree that the indication for use of biologic implant is mutual.

Locations
Other Locations
Canada
Foothills Medical Centre, Faculty of Medicine
RECRUITING
Calgary
Time Frame
Start Date: 2017-10-26
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
Active_comparator: Strattice biologic mesh
Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Experimental: Permacol biologic mesh
Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: University of Calgary

This content was sourced from clinicaltrials.gov