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

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01010464
Collaborator
Genzyme, a Sanofi Company (Industry)
0
Enrollment
1
Location
2
Arms
19
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adhesion Reduction Plan
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Extent and severity of adhesions [Each abdominal re-entry and re-exploration]

    Secondary Outcome Measures

    1. Time for lysis of adhesions [Each abdominal re-entry and re-exploration]

    2. Incidence of complications [Hospital admission]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Maryland Medical Center Baltimore Maryland United States 21201-1595

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • Genzyme, a Sanofi Company

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    William Chiu, Associate Professor of Surgery, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT01010464
    Other Study ID Numbers:
    • HP-00043289
    First Posted:
    Nov 10, 2009
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by William Chiu, Associate Professor of Surgery, University of Maryland, Baltimore
    Adhesions
    Open abdomen
    Laparotomy
    Additional relevant MeSH terms:
    Tissue Adhesions

    Study Results

    No Results Posted as of Apr 6, 2020