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

Not Applicable

Withdrawn

• Conditions: Open Abdomen
• Interventions: Procedure: Adhesion Reduction Plan

• Registration Number: NCT01010464
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Study Timeline

• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Study Start: 2011-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Trauma patients with open abdomen after initial laparotomy
• Emergency surgery patients with open abdomen after initial laparotomy
• Able to obtain consent from patient or LAR before any research initiated

Exclusion Criteria

• Seprafilm application at initial laparotomy
• Patient is a prisoner
• Inability to obtain informed consent
• Consentable person does not speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesion Reduction Plan	Adhesion Reduction Plan	Lysis of adhesions and application of Seprafilm

Primary Outcome Measures

Name	Time	Method
Extent and severity of adhesions	Each abdominal re-entry and re-exploration

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	Hospital admission
Time for lysis of adhesions	Each abdominal re-entry and re-exploration

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States