A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part？ Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part？ Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10) days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10) days and 3 months (±14 days) after surgery.This trial aims to assess, whether the intra-peritoneal application of A-Part？ Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.NCT00646412Post surgical adhesions are quite common, i.e. they can affect up to 93% of patients undergoing abdominal surgery [1,2]. Adhesions are internal scars developing after trauma and involving the injured tissue and the peritoneum [3]. The magnitude of the problems caused by adhesions was highlighted by several studies [4-7]. Depending on the location and the structure of the adhesion serious complications may be caused thereby, such as large and small bowel obstruction. Pelvic adhesions are associated with infertility in 15-20% of cases [8]. A number of products that help to reduce or to prevent tissue adhesion are marketed [2]. Barrier materials in various forms such as films, viscous gels and intra-peritoneal solutions have been used clinically for the prevention of surgical adhesions. However, these materials have had limited succ