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

April 2, 2020 updated by: William Chiu, University of Maryland, Baltimore

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adhesion Reduction Plan
Lysis of adhesions and application of Seprafilm
Procedure: Adhesion Reduction Plan
Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane
Other Names:
  • Seprafilm
No Intervention: Standard Management
Standard management and no application of Seprafilm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extent and severity of adhesions
Time Frame: Each abdominal re-entry and re-exploration
Each abdominal re-entry and re-exploration

Secondary Outcome Measures

Outcome Measure
Time Frame
Time for lysis of adhesions
Time Frame: Each abdominal re-entry and re-exploration
Each abdominal re-entry and re-exploration
Incidence of complications
Time Frame: Hospital admission
Hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: William C. Chiu, M.D., University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00043289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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