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

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open Abdomen

Intervention: Adhesion Reduction Plan (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
William C. Chiu, M.D., Principal Investigator, Affiliation: University of Maryland

Overall contact:
William C. Chiu, M.D., Phone: 410-328-1205, Email: wchiu@umm.edu

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Extent and severity of adhesions

Secondary outcome:

Time for lysis of adhesions

Incidence of complications

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

William C. Chiu, M.D., Phone: 410-328-1205, Email: wchiu@umm.edu

University of Maryland Medical Center, Baltimore, Maryland 21201-1595, United States; Not yet recruiting
William C. Chiu, M.D., Principal Investigator
Additional Information

Starting date: January 2011
Last updated: October 2, 2010

Page last updated: August 23, 2015

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