Hernia IncisionalNCT04312165
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
A study testing Duramesh Laparotomy Closure and Conventional suture closure in people with Hernia Incisional and Suture, Complication, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hernia Incisional, Suture, Complication
- What is being tested?
- Duramesh Laparotomy Closure and Conventional suture closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
- Metastatic cancer
- Pregnancy
- Immunosuppression
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Shock Trauma
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
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
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.
Read the 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.
- Conditions
- Hernia Incisional, Suture, Complication
- Being tested
- Duramesh Laparotomy Closure, Conventional suture closure
- Keywords
- mesh, suture, laparotomy, incisional hernia, prevention
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duramesh Laparotomy ClosureDevice
Also called mesh suture
Closure of midline laparotomy incision with experimental suture
Conventional suture closureDevice
Also called polydiaxanone, PDS
Closure of midline laparotomy incision with standard suture
| Study group | Role | What they receive |
|---|---|---|
| Duramesh Laparotomy Closure | Experimental | 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. Receives: Device: Duramesh Laparotomy Closure |
| Control group-Conventional suture closure | Active comparator | 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. Receives: Device: Conventional suture closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical site infection
hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality
Measured: 30 days
Secondary outcomes (18)
Intraoperative endpoints
length of surgery procedure, length of hospital stay, length of laparotomy incision
Measured: day zero, time of implantation
Rate of incisional hernia formation
clinical or radiographic evidence of hernia formation
Measured: within 12 months
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Measured: 1 month
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Measured: 3 month
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Measured: 6 months
Quality of life patient reported outcomes
SF-36 questionnaire, Scale 0-100, 100 implies no disability
Measured: 12 months
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Measured: 1 month
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Measured: 3 months
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Measured: 6 months
Abdominal wall function patient reported outcomes
HerQles patient reported outcomes for abdominal wall function, Scale 0-100, 100 implies excellent abdominal wall function
Measured: 12 months
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Measured: 1 month
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Measured: 3 months
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Measured: 6 months
Pain patient reported outcome
Numerical pain rating scale, Scale 0-10, 0 implies no pain
Measured: 12 months
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Measured: 1 month
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Measured: 3 months
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Measured: 6 months
Visual analog scale pain, patient reported outcome
Wong-Baker faces pain scale, Scale 0-10, 0 implies no pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: Financial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia IncisionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization between Duramesh closure and standard suture closure
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Gregory Dumanian, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312165
- Sponsor's protocol ID
- HP-00083440
- Status last verified
- May 2023
- First submitted
- 8 Mar 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04312165
- Acronym / sponsor ID
- HP-00083440
- Conditions
- Hernia Incisional, Suture, Complication
- Keywords
- mesh, suture, laparotomy, incisional hernia, prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Financial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization between Duramesh closure and standard suture closure
| Arm | Type | Receives |
|---|---|---|
| Duramesh Laparotomy Closure | Experimental | Device: Duramesh Laparotomy ClosurePatients 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. |
| Control group-Conventional suture closure | Active comparator | Device: Conventional suture closurePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
- Metastatic cancer
- Pregnancy
- Immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duramesh Laparotomy ClosureAlso: mesh sutureClosure of midline laparotomy incision with experimental suture | Device | Duramesh Laparotomy Closure |
| Conventional suture closureAlso: polydiaxanone, PDSClosure of midline laparotomy incision with standard suture | Device | Control group-Conventional suture closure |
Primary outcome
Rate of surgical site infection
Time frame: 30 days
hematoma, seroma, dehiscence, fistula, bowel obstruction, removal infected mesh suture, return to OR, readmission, mortality
18 secondary outcomes
Intraoperative endpoints
Time frame: day zero, time of implantation
Rate of incisional hernia formation
Time frame: within 12 months
Quality of life patient reported outcomes
Time frame: 1 month
Quality of life patient reported outcomes
Time frame: 3 month
Quality of life patient reported outcomes
Time frame: 6 months
Quality of life patient reported outcomes
Time frame: 12 months
Abdominal wall function patient reported outcomes
Time frame: 1 month
Abdominal wall function patient reported outcomes
Time frame: 3 months
Abdominal wall function patient reported outcomes
Time frame: 6 months
Abdominal wall function patient reported outcomes
Time frame: 12 months
Pain patient reported outcome
Time frame: 1 month
Pain patient reported outcome
Time frame: 3 months
Pain patient reported outcome
Time frame: 6 months
Pain patient reported outcome
Time frame: 12 months
Visual analog scale pain, patient reported outcome
Time frame: 1 month
Visual analog scale pain, patient reported outcome
Time frame: 3 months
Visual analog scale pain, patient reported outcome
Time frame: 6 months
Visual analog scale pain, patient reported outcome
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duramesh Laparotomy Closure and Conventional suture closure in people with Hernia Incisional and Suture, Complication, run by Uniformed Services University of the Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.