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

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010464
First Posted: November 10, 2009
Last Update Posted: August 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Maryland
  Purpose
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 Intervention
Open Abdomen Procedure: Adhesion Reduction Plan

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Extent and severity of adhesions [ Time Frame: Each abdominal re-entry and re-exploration ]

Secondary Outcome Measures:
  • Time for lysis of adhesions [ Time Frame: Each abdominal re-entry and re-exploration ]
  • Incidence of complications [ Time Frame: Hospital admission ]

Enrollment: 0
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Seprafilm
No Intervention: Standard Management
Standard management and no application of Seprafilm

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010464


Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
Sponsors and Collaborators
University of Maryland
Genzyme, a Sanofi Company
Investigators
Principal Investigator: William C. Chiu, M.D. University of Maryland
  More Information

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01010464     History of Changes
Other Study ID Numbers: HP-00043289
First Submitted: November 9, 2009
First Posted: November 10, 2009
Last Update Posted: August 23, 2016
Last Verified: October 2010

Keywords provided by University of Maryland:
Adhesions
Open abdomen
Laparotomy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes