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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Open Abdomen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adhesion Reduction Plan

Lysis of adhesions and application of Seprafilm

Group Type EXPERIMENTAL

Adhesion Reduction Plan

Intervention Type PROCEDURE

Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane

Standard Management

Standard management and no application of Seprafilm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adhesion Reduction Plan

Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane

Intervention Type PROCEDURE

Other Intervention Names

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Seprafilm

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No