Recruiting
Phase 2
Phase 3

Biologic Mesh Materials

Sponsor:

University of Calgary

Code:

NCT02703662

Conditions

Ventral Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Strattice biologic mesh

Permacol biologic mesh

Study Details

Brief 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.

Conditions

Ventral Hernia

Study ID

NCT02703662

Start date

Oct 26, 2017

Status verified date

Feb, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be excluded if they are unable or unwilling to provide informed consent.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Strattice biologic mesh

Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.

Permacol biologic mesh

Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.

Primary outcome measure

  • The percentage of hernia recurrence in patients received the biologic meshes. [ Time Frame: 12 months postoperation ]

Central Contacts and Locations

Locations

Foothills Medical Centre, Faculty of Medicine

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Chad G Ball, MD

403-944-3417ball.chad@gmail.com

Jimmy Xiao, PhD

403-944-8750jimmy.xiao@albertahealthservices.ca

Principal Investigator:

Chad G Ball, MD

More Information

Sponsor

University of Calgary

Last update posted

Feb 3, 2023

Last verified

Feb, 2023

Keywords

  • Biologic mesh
  • abdominal wall reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-02-03.