Open Access Study protocol

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

Reinhold Lang1, Petra Baumann2, Karl-Walter Jauch1, Claudia Schmoor3, Christine Weis4, Erich Odermatt4 and Hanns-Peter Knaebel2*

Author Affiliations

1 Department of Surgery, University Munich-Großhadern, Marchioninistrasse 15, 81377 Munich, Germany

2 Aesculap AG, Department of Clinical Science, Am Aesculap Platz, 78532 Tuttlingen, Germany

3 Clinical Trials Centre, Elsässer Strasse 2, 79110 Freiburg, Germany

4 Aesculap AG, R&D Closure Technologies, 78532 Tuttlingen, Germany

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BMC Surgery 2010, 10:20  doi:10.1186/1471-2482-10-20

Published: 6 July 2010

Abstract

Background

Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed.

Methods/Design

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.

Discussion

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.

Trial registration

NCT00646412