An interventional study of Adhesion Reduction Plan in Open Abdomen, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
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.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
Browse Tissue Adhesions studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
Lysis of adhesions and application of Seprafilm
Procedure: Adhesion Reduction Plan
Standard management and no application of Seprafilm
Lysis of adhesions and application of a minimum of 4 sheets of a sodium hyaluronate-based bioresorbable membrane
Also known as: Seprafilm
Extent and severity of adhesions
Time frame: Each abdominal re-entry and re-exploration
Time for lysis of adhesions
Time frame: Each abdominal re-entry and re-exploration
Incidence of complications
Time frame: Hospital admission
This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore