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

Completed · Not applicable

Conditions studied: Open Abdomen, Abdominal Adhesions, Trauma, Wounds and Injury

In brief

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.

Key facts

Study ID

NCT01594385

Run by

Stan Stawicki

People needed

30

Starts

2010-04-01

Expected to finish

2013-12-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Trauma patients undergoing DC/OA management for traumatic injury
• Age 18+
• Life expectancy longer than 48 hours

You may not qualify if…

• Prisoners
• Pregnant patients
• Younger than 18 years of age

Where it is running

• Cooper University Hospital — Camden, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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