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A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group — A-PART  

Adhesions Clinical Trial

Official title:
A Prospective, Randomised, Controlled, Single-blind Phase I-II Clinical Trial on the Safety of A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group

Clinical Trial Summary

The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.

Clinical Trial Description

Primary Objective:

• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.

Secondary Objectives:

- To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)

- To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00646412
Study type Interventional
Source Aesculap AG
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2008
Completion date August 2010
View Details
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