NCT02168231

Abdominal Wall Repair With Strattice in Germany: a Cohort Study

Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented. In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh. The aim of this study is to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.

Conditions

• Hernia of Abdominal Wall
• Biologic Mesh
• Strattice

Interventions

Type	Name	Description
PROCEDURE	Complex abdominal wall repair Strattice	Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2014-06-20
• Last updated: 2018-08-07

Locations

6 sites across 1 country: Germany