A post approval study to evaluate the safety and efficacy of Gentafoil
Research type
Research Study
Full title
A Post approval study to evaluate the safety and efficacy of Gentafoil resorb for the prevention of tissue adhesions.
IRAS ID
265693
Contact name
Stephen James Lipscombe
Contact email
Sponsor organisation
Advanced Medical Solutions
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Title- Post-approval study to evaluate the safety and efficacy of Genta-Foil resorb® for the prevention of tissue adhesions.
The purpose of the study is evaluate the performance and safety of the Genta Foil® resorb® in the prevention of tissue adhesions. The device is a transparent collagen foil that forms a temporary barrier between the functional structures during the critical phase of wound healing. As a result, the ability of the tissue layers to slide against each other is retained and prevents tissue adhesions.
The collagen foil supports and promotes wound healing. The collagen matrix forms a guiding structure and promotes the adhesion of actively dividing cells.The incorporated Gentamicin breakdown of the collagen foil occur simultaneously, which means that the implanted foil is protected from external contamination caused either by micro-organisms ascending along the wound drainage by micro-organisms introduced and spread during surgery.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0281
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion