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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010464

Enrollment

Registered

2009-11-10

Start date

2011-01-31

Completion date

2012-08-31

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Abdomen

Keywords

Adhesions, Open abdomen, Laparotomy

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.

Interventions

PROCEDUREAdhesion Reduction Plan

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Extent and severity of adhesions	Each abdominal re-entry and re-exploration

Secondary

Measure	Time frame
Time for lysis of adhesions	Each abdominal re-entry and re-exploration
Incidence of complications	Hospital admission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026