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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Open Abdomen

Intervention / Treatment
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* Procedure: Adhesion Reduction Plan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhesion Reduction Plan<br>Lysis of adhesions and application of Seprafilm | Procedure: Adhesion Reduction Plan<br>* Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane<br>* Other names: Seprafilm;|
| No Intervention: Standard Management<br>Standard management and no application of Seprafilm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent and severity of adhesions |  | Each abdominal re-entry and re-exploration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for lysis of adhesions |  | Each abdominal re-entry and re-exploration | 
| Incidence of complications |  | Hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesions, Open abdomen, Laparotomy