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

Open Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01010464
• Other study ID #: HP-00043289
• Status: Withdrawn
• Phase: N/A
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Open Abdomen
• Tissue Adhesions

Intervention

Procedure:
• Adhesion Reduction Plan
Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent and severity of adhesions		Each abdominal re-entry and re-exploration
Secondary	Time for lysis of adhesions		Each abdominal re-entry and re-exploration
Secondary	Incidence of complications		Hospital admission