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Biological implants for the reconstruction of complex, contaminated abdominal wall defects.


- candidate number14806
- NTR NumberNTR3972
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-apr-2013
- Secondary IDs13-N-48 
- Public TitleBiological implants for the reconstruction of complex, contaminated abdominal wall defects.
- Scientific TitleBiological implants for the reconstruction of complex, contaminated abdominal wall defects.
- ACRONYM
- hypothesisThe use of a biological mesh in a contaminated/infected field is expected to have better outcomes on mortality, morbidity, performance, durability, postoperative complications and reoperations compared to use of a synthetic mesh. One of the explanations is because of their compliance with the host leukocyte response.
The costs of the more expensive biological implant weigh against the benefits of its use as explained above.
- Healt Condition(s) or Problem(s) studiedComplex, contaminated abdominal wall defects, Reconstruction
- Inclusion criteria1. Patients with complex, contaminated wall defects, repaired with a biological mesh;
2. Patients with complex, contaminated wall defects, repaired with a synthetic mesh.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 26-apr-2013
- planned closingdate1-dec-2013
- Target number of participants80
- InterventionsN/A
- Primary outcomeThe primary outcome measure is the possible advantage of a biological mesh compared to the synthetic mesh, expressed in recurrence, morbidity, durability of the mesh (measured in the time passed postoperatively) and postoperative complications (measured in sepsis, reoperation and fistulation).
- Secondary outcomeThe secondary outcome measure is the cost analysis of the biological mesh compared to the synthetic mesh determined in comparison with the case-matched control group.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Tina Loon, van
- CONTACT for SCIENTIFIC QUERIES Tina Loon, van
- Sponsor/Initiator Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medical Center, Heerlen
- PublicationsN/A
- Brief summaryBackground: Approximately 2-24%% of the 100.000 laparotomy procedures performed in The Netherlands annually result in an incisional or abdominal wall hernia. Use of synthetic mesh is contra-indicated when the field is complicated, infected and/or contaminated because of the risk of adhesions, (chronic) sepsis and erosion. The results of the modern biological implants demonstrate that the biological grafts become recellularized and revascularized without being resorbed with fewer adhesions compared to synthetic meshes. Permacol, acellular porcine dermis, is the biological mesh of choice in Atrium Medical Centre Heerlen and Orbis Medical Centre Sittard.
Objective: A retrospective review of Atrium Medical Centre’s in Heerlen and Orbis Medical Centre’s in Sittard experience using Permacol for the repair of abdominal wall defects and a cost-effective analysis comparing the use of a synthetic mesh versus Permacol in complex abdominal wall hernia repair.
Methods: Retrospective review of medical records of patients undergoing abdominal wall reconstruction with Permacol compared with a case-matched control group in which a synthetic mesh has been used to determine the advantages and cost-effectiveness of the biological mesh.
- Main changes (audit trail)
- RECORD26-apr-2013 - 3-jun-2013


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