Back to results

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

Primary Purpose

Open Abdomen

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adhesion Reduction Plan

About this trial

This is an interventional prevention trial for Open Abdomen focused on measuring Adhesions, Open abdomen, Laparotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adhesion Reduction Plan

Standard Management

Arm Description

Lysis of adhesions and application of Seprafilm

Standard management and no application of Seprafilm

Outcomes

Primary Outcome Measures

Extent and severity of adhesions

Secondary Outcome Measures

Time for lysis of adhesions

Incidence of complications

Full Information

NCT ID

NCT01010464

First Posted

November 9, 2009

Last Updated

April 2, 2020

Sponsor

University of Maryland, Baltimore

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01010464

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Abdomen

Keywords

Adhesions, Open abdomen, Laparotomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adhesion Reduction Plan

Arm Type

Experimental

Arm Description

Lysis of adhesions and application of Seprafilm

Arm Title

Standard Management

Arm Type

No Intervention

Arm Description

Standard management and no application of Seprafilm

Intervention Type

Procedure

Intervention Name(s)

Adhesion Reduction Plan

Other Intervention Name(s)

Seprafilm

Intervention Description

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

Primary Outcome Measure Information:

Title

Extent and severity of adhesions

Time Frame

Each abdominal re-entry and re-exploration

Secondary Outcome Measure Information:

Title

Time for lysis of adhesions

Time Frame

Each abdominal re-entry and re-exploration

Title

Incidence of complications

Time Frame

Hospital admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C. Chiu, M.D.

Organizational Affiliation

University of Maryland, College Park

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201-1595

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs