Trial of Routine Abdominal Wall Closure Versus Reinforcement With TIGR Matrix Onlay

Purpose and aims

Wound dehiscence (WD), i.e. the rupturing of the wound along sutures, and incisional hernias (IH), i.e. protrusion of the peritoneum with its contents through the incompletely healed abdominal wall, are common and potentially serious complications after abdominal surgery. Various medical reports indicate that 10-35% of all laparotomy patients suffer from wound complications, leading to extended hospital stay and severe patient morbidity. One approach to mitigate this problem is to use prophylactic surgical mesh at surgery in order to reinforce the suture line. Conventional surgical meshes commonly composed of polypropylene have been successfully demonstrated to reduce the incidence of IH by approximately 70%. However, a synthetic polypropylene mesh is a permanent implant, which may cause chronic inflammation, seroma, pain and infection. Furthermore, if additional surgery is necessary, the implanted polypropylene mesh complicates the procedure.

A solution to the problem of suture reinforcement is the use of a resorbable (biologically degradable) non-permanent mesh that provides structural support during the healing phase, while gradually being absorbed. The TIGR Matrix Surgical Mesh is a completely synthetic resorbable mesh that has the desired properties for use in non-permanent wound reinforcement. The patented TIGR mesh is a weave of two different types of fibers, one fast and one slowly resorb able. This allows for resorbtion to take place in two distinct stages. The fast fiber is a copolymer of glycotide, lactide and trimethylene carbonate, while the slow fiber is a copolymer of lactide and trimethylene carbonate. The two-stage resorbtion of the matrix provides for initial high strength wound support, with gradual loss of mechanical strength as the fibers are degraded. The fast fibers lose mechanical strength after two weeks, with full resorbtion in approximately four months; the slow fibers lose mechanical strength after 9 months, with full resorbtion following 3 years.

The TIGR® Matrix Surgical Mesh has been evaluated in animal models and has been included in clinical studies for abdominal wall repair and breast surgery. A pilot study with the use of the TIGR® mesh has successfully demonstrated its safety in prevention of IH.

In order to extend the clinical use of the TIGR mesh for prophylactic management of WD and IH, we intend to carry out a multicenter randomized clinical study to further evaluate the safety and effectiveness of the TIGR® mesh in patients with increased risk of developing post-surgical wound complications. The intended study will have the impact of widespread prophylactic use of the TIGR mesh in surgery worldwide, resulting in significantly decreased hospital costs and improved quality of life for patients.