NCT00646412

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Adhesions
• Abdominal Cavity

Interventions

Type	Name	Description
DEVICE	A-Part® Gel	10 - 20 ml of A-Part® Gel will be administered before abdominal wall closure in a standardised fashion

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2008-03-28
• Last updated: 2015-09-09

Locations

1 site across 1 country: Germany