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

University of Maryland Baltimore (UMB)

Status: Withdrawn

Conditions: Open Abdomen

Treatments: Procedure: Adhesion Reduction Plan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01010464

HP-00043289

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Adhesion Reduction Plan

Experimental group

Description:

Lysis of adhesions and application of Seprafilm

Treatment:

Procedure: Adhesion Reduction Plan

Standard Management

No Intervention group

Description:

Standard management and no application of Seprafilm