DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
Primary Purpose
Hernia Incisional, Suture, Complication
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duramesh Laparotomy Closure
Conventional suture closure
Sponsored by
About this trial
This is an interventional treatment trial for Hernia Incisional focused on measuring mesh, suture, laparotomy, incisional hernia, prevention
Eligibility Criteria
Inclusion Criteria:
- Midline laparotomy 5 cm (2 inches) long
- Urgent or emergent surgery following trauma
- Urgent or emergent surgery for diverticulitis
- Urgent or emergent surgery for large or small bowel obstruction
- Urgent or emergent surgery for exploratory laparotomy for acute abdomen
- Urgent or emergent surgery for exploratory laparotomy for intraabdominal hemorrhage
Exclusion criteria
- Inability to provide informed consent
- Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
- Metastatic cancer
- Pregnancy
- Immunosuppression
Sites / Locations
- University of Maryland Shock Trauma
- Walter Reed National Military Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Duramesh Laparotomy Closure
Control group-Conventional suture closure
Arm Description
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.
Outcomes
Primary Outcome Measures
Rate of surgical site infection
hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality
Secondary Outcome Measures
Intraoperative endpoints
length of surgery procedure, length of hospital stay, length of laparotomy incision
Rate of incisional hernia formation
clinical or radiographic evidence of hernia formation
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Full Information
NCT ID
NCT04312165
First Posted
March 8, 2020
Last Updated
May 8, 2023
Sponsor
Uniformed Services University of the Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04312165
Brief Title
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Financial
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uniformed Services University of the Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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 (2:1) 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 weeks,1 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 weeks,1 month, 3 months, 6 months, 12 months). Hernia outcomes will be based on physical examination, with ultrasound used for any uncertainties.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia Incisional, Suture, Complication
Keywords
mesh, suture, laparotomy, incisional hernia, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomization between Duramesh closure and standard suture closure
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duramesh Laparotomy Closure
Arm Type
Experimental
Arm Description
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.
Arm Title
Control group-Conventional suture closure
Arm Type
Active Comparator
Arm Description
Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 Duramesh suture or standard suture, which is a #1 slowly-absorbing PDS single strand or looped suture based on surgeon preference.
Intervention Type
Device
Intervention Name(s)
Duramesh Laparotomy Closure
Other Intervention Name(s)
mesh suture
Intervention Description
Closure of midline laparotomy incision with experimental suture
Intervention Type
Device
Intervention Name(s)
Conventional suture closure
Other Intervention Name(s)
polydiaxanone, PDS
Intervention Description
Closure of midline laparotomy incision with standard suture
Primary Outcome Measure Information:
Title
Rate of surgical site infection
Description
hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Intraoperative endpoints
Description
length of surgery procedure, length of hospital stay, length of laparotomy incision
Time Frame
day zero, time of implantation
Title
Rate of incisional hernia formation
Description
clinical or radiographic evidence of hernia formation
Time Frame
within 12 months
Title
Quality of life patient reported outcomes
Description
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Time Frame
1 month
Title
Quality of life patient reported outcomes
Description
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Time Frame
3 month
Title
Quality of life patient reported outcomes
Description
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Time Frame
6 months
Title
Quality of life patient reported outcomes
Description
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Time Frame
12 months
Title
Abdominal wall function patient reported outcomes
Description
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Time Frame
1 month
Title
Abdominal wall function patient reported outcomes
Description
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Time Frame
3 months
Title
Abdominal wall function patient reported outcomes
Description
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Time Frame
6 months
Title
Abdominal wall function patient reported outcomes
Description
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Time Frame
12 months
Title
Pain patient reported outcome
Description
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Time Frame
1 month
Title
Pain patient reported outcome
Description
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Time Frame
3 months
Title
Pain patient reported outcome
Description
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Time Frame
6 months
Title
Pain patient reported outcome
Description
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Time Frame
12 months
Title
Visual analog scale pain, patient reported outcome
Description
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Time Frame
1 month
Title
Visual analog scale pain, patient reported outcome
Description
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Time Frame
3 months
Title
Visual analog scale pain, patient reported outcome
Description
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Time Frame
6 months
Title
Visual analog scale pain, patient reported outcome
Description
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Midline laparotomy 5 cm (2 inches) long
Urgent or emergent surgery following trauma
Urgent or emergent surgery for diverticulitis
Urgent or emergent surgery for large or small bowel obstruction
Urgent or emergent surgery for exploratory laparotomy for acute abdomen
Urgent or emergent surgery for exploratory laparotomy for intraabdominal hemorrhage
Exclusion criteria
Inability to provide informed consent
Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
Metastatic cancer
Pregnancy
Immunosuppression
Facility Information:
Facility Name
University of Maryland Shock Trauma
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
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