Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04312165
Status:
WITHDRAWN
Last Update Posted:
2023-05-10
First Post:
2020-03-08
Brief Title:
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery A Prospective Clinical Trial to Evaluate the Safety and Efficacy of DuraMesh Laparotomy Closure Following Trauma or Emergency Surgery and for Delayed Primary Closure of the Abdomen
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed project aims to evaluate the safety of DuraMesh suture for laparotomy closure in an emergent setting while also providing preliminary efficacy data with regard to incisional hernia prevention Conventional techniques for laparotomy closure in the setting of an emergency laparotomy or delayed abdominal closure suffer from a lack of durability with incisional hernia rates of 30-34 reported While prophylactic planar mesh placement has emerged as a cost-effective strategy to prevent hernia formation in the clean elective laparotomy setting higher rates of surgical site complications and increased technical complexity preclude its use in the emergency or contaminated setting Utilized exactly like conventional suture without any change in surgical closure technique DuraMesh provides the durability of planar mesh reinforcement without the marked increase in foreign material or added surgical complexity As a result DuraMesh is the only hernia prevention strategy that can be forward-deployed in support of the injured warfighter While this study is specifically targeted to a gap in the care of the injured warfighter the potential benefits extend well beyond the military applications With over 2 million laparotomies performed annually in the United States and approximately 20 of these resulting in an incisional hernia the need for an alternative abdominal wall closure strategy is equally dire in the civilian setting This clinical trial represents an opportunity to drive the needed paradigm shift towards prevention rather than costly management of incisional hernias The investigators anticipate this work will rapidly lead to further research including providing the preliminary data necessary to launch a multi-center randomized controlled trial to assess the clinical efficacy of DuraMesh for hernia prevention in both the emergent and elective operative settings
Detailed Description:
This is a multisite randomized control proof-of-concept trial to evaluate the safety of DuraMesh laparotomy closure in the trauma and emergency laparotomy setting Approximately 120 patients will be randomized 21 to DuraMesh laparotomy closure versus conventional suture closure 1 DuraMesh will be provided for patients assigned to the DuraMesh treatment arm Patients will participate in a one-year follow-up regime 2 weeks1 month 3 months 6 months and 12 months
Primary Laparotomy Closure Treatment 1 Study Group - DuraMesh Laparotomy Closure DLC Treatment 2 Control Group - Conventional Suture Closure CSC
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either 1 DuraMesh suture or conventional laparotomy closure using size 1 slowly-absorbing PDS single strand or looped suture based on surgeon preference All patients will be assessed for post-operative complications at 2 weeks 1 month 3 months 6 months and 12 months postoperatively Patients will also be assessed for incisional hernia formation at the same post-operative time points 2 weeks1 month 3 months 6 months 12 months Hernia outcomes will be based on physical examination with ultrasound used for any uncertainties
Primary Laparotomy Closure Treatment 1 Study Group - DuraMesh Laparotomy Closure DLC Treatment 2 Control Group - Conventional Suture Closure CSC
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either 1 DuraMesh suture or conventional laparotomy closure using size 1 slowly-absorbing PDS single strand or looped suture based on surgeon preference All patients will be assessed for post-operative complications at 2 weeks 1 month 3 months 6 months and 12 months postoperatively Patients will also be assessed for incisional hernia formation at the same post-operative time points 2 weeks1 month 3 months 6 months 12 months Hernia outcomes will be based on physical examination with ultrasound used for any uncertainties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None