NCT00512356

Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.

Conditions

• Intraperitoneal Adhesions

Interventions

Type	Name	Description
BIOLOGICAL	Anti-Adhesion Product	Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.

Timeline

• Start date: 2000-12-01
• Primary completion: 2003-02-25
• Completion: 2003-04-01
• First posted: 2007-08-07
• Last updated: 2017-08-04

Locations

7 sites across 3 countries: Denmark, Poland, Sweden