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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Maryland.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01010464
First received: November 9, 2009
Last updated: October 2, 2010
Last verified: October 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time for lysis of adhesions [ Time Frame: Each abdominal re-entry and re-exploration ] [ Designated as safety issue: No ]
  • Incidence of complications [ Time Frame: Hospital admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010464

Contacts
Contact: William C. Chiu, M.D. 410-328-1205 wchiu@umm.edu
Contact: Almaz I. Holmatova, M.D. 410-328-3657 aholmatova@stapa.umm.edu

Locations
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201-1595
Principal Investigator: William C. Chiu, M.D.         
Sponsors and Collaborators
University of Maryland
Genzyme, a Sanofi Company
Investigators
Principal Investigator: William C. Chiu, M.D. University of Maryland
  More Information

No publications provided

Responsible Party: William C. Chiu, M.D. / Associate Professor of Surgery, University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT01010464     History of Changes
Other Study ID Numbers: HP-00043289
Study First Received: November 9, 2009
Last Updated: October 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Adhesions
Open abdomen
Laparotomy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014