NCT01010464

An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen

Effect of an Adhesion Reduction Plan on Enteric Adhesions, Obstruction, and Fistulae in the Management of the Surgical Open Abdomen: A Prospective, Randomized Clinical Trial in Trauma and Emergency General Surgery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Detailed description

Adhesions are a common consequence of abdominal surgery. Trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. Adhesions appear soon after the initial operation and gradually mature within days. The effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. Complications of adhesions include enteric obstruction and enterocutaneous fistulae. This study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.

Conditions

• Open Abdomen

Interventions

Type	Name	Description
PROCEDURE	Adhesion Reduction Plan	Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-11-10
• Last updated: 2020-04-06

Locations

1 site across 1 country: United States