More than 140,000 patients in Sweden undergo open abdominal wall surgery every year. Common complications are wound dehiscence and incisional hernias. A wound dehiscence, i.e. a rupture of the wound along the stitches in the fascia, may turn into a complete dehiscence if the skin sutures also rupture and the abdominal contents protrude through the entire wall. Wound dehiscence may develop into a lethal condition, especially in the elderly. It may lead to bowel lesions, infections and organ failure. The risk of repeated wound dehiscence also increases once dehiscence has occurred.
Despite the main risk factors for wound dehiscence being identified and the technique for closing the abdominal wall improved in recent years, the incidence of wound dehiscence after colorectal surgery is still around 5%. The measurable costs, including costs for re-operation, prolonged hospital stay and other interventions, are very high. Efforts to prevent wound dehiscence may thus be very effective, not only reducing healthcare costs but also improving health-related quality of life.
It has previously been shown that placement of a permanent polypropylene mesh onlay prophylactically decreases the risk of incisional hernia within one year. There are, however, problems with leaving a mesh permanently in place, including the risk of developing seroma, infections and persisting pain. One way to avoid these drawbacks would be to use a resorbable mesh, where any mesh-related problems will eventually cease as the mesh resorbs.
The controlled randomized multicenter study will include 400 patients from up to 10 centers all around Sweden. For inclusion, patients should have at least two risk factors. These can be factors that increase the pressure on the wound, e.g. obesity, or factors impairing wound healing, e.g. diabetes.
Primary investigator is Associate Professor Gabriel Sandblom, Karolinska University Hospital, Stockholm. “We are very happy to start including patients in this pivotal study and believe we will soon be up and running including patients in many centers,” he notes.
About Novus Scientific
|Novus Scientific AB (www.novusscientific.com) develops, manufactures and markets resorbable implants that help the body's own healing. Headquarters, research and production are located in Uppsala and sales are made through distributors in a growing number of countries, currently around twenty-five. The company owners and management come from the Uppsala-based Radi Medical Systems AB, which was sold in 2008 to St. Jude Medical Inc, St Paul, USA. |
TIGR® Matrix (www.TIGRmatrix.com) is a slowly degradable synthetic surgical mesh that contributes mechanical strength until the body itself recreates tissue strength. It is then excreted through natural pathways. TIGR® Matrix Surgical Mesh is used today in a variety of surgical application areas to reinforce soft tissue where weakness exists
For more information about TIGR® Matrix, visit: www.TIGRmatrix.com