A Phase 2/3 interventional study of Strattice biologic mesh and Permacol biologic mesh in Ventral Hernia, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
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.
Complex abdominal wall reconstructions utilize advanced techniques that include, but are not limited to, component separation, modified component separation, and free tissue flap reconstruction. Data suggests that recurrence rates are lowered with the insertion of mesh supporting materials. More specifically, synthetic mesh utilization during repair of simple clean ventral hernias reduces hernia recurrence by over 50% when compared to suture closure alone. Unfortunately in the presence of microbial contamination or infection, there is a marked increase in hernia recurrence and mesh infection using synthetic prostheses. Biologic meshes however are established options for use in abdominal wall reconstruction in the presence of both field contamination and infection. These indications, as well as others, for biologic materials include, but are not limited to, patients with chronic immunosuppression, infected fields, colonized fields (i.e. preceding synthetic mesh), the need to place the product within the peritoneal cavity (underlay), and patients with complex losses of domain. It should also be noted that there may be significant utility in their use of biologic materials in a much broader range of indications, but the economic cost of these products have clearly tempored wider indications for overall use.
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.
Given the nearly 2-fold difference in cost between the 2 included biologic meshes, equivalence with regard to recurrence and postoperative complications would represent a massive economic savings to the public health care system.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Device: Strattice biologic mesh
Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.
Device: Permacol biologic mesh
Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.
Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.
The percentage of hernia recurrence in patients received the biologic meshes.
Time frame: 12 months postoperation
The percentage of wound infection of the participants.
Time frame: 12 months postoperation
The days of hospital stay post the abdominal wall reconstruction procedure.
Time frame: 12 months postoperation
Plan to share: No
Started Oct 2017 (actual). Primary completion is estimated for Oct 2025, 96 months after the start.
How these figures are worked out, and which studies are left out of them.
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