Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01010464
Status:
WITHDRAWN
Last Update Posted:
2020-04-06
First Post:
2009-11-09
Brief Title:
An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None