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Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients

NCT01594385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-11-20

Study results available
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Summary

The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:

* the number and intensity of adhesions,
* whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,
* rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and
* whether there is any difference between treatment groups regarding patient functional recovery.

Conditions

  • Open Abdomen
  • Abdominal Adhesions
  • Trauma
  • Wounds and Injury

Interventions

BIOLOGICAL

Seprafilm

Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas: * Two Seprafilm pieces between the liver and the anterior abdominal wall * Four pieces over the exposed bowel surfaces anteriorly * Two slightly staggered pieces of Seprafilm in each colic gutter * Two pieces in the pelvic area. * If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair.

Sponsors & Collaborators

  • Stan Stawicki

    lead OTHER

Principal Investigators

  • Stanislaw P Stawicki, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01594385 on ClinicalTrials.gov