Laparotomy Closure After Abdominal SurgeryMOMENTUM RCTNCT05804136
Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
A study testing Duramesh and Polydioxanone suture in people with Laparotomy Closure After Abdominal Surgery, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy Closure After Abdominal Surgery
- What is being tested?
- Duramesh and Polydioxanone suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
- Isolated ostomy site takedown with or without parastomal hernia
- Patient accepts participation and gives informed consent
- Patient and investigator signed and dated the informed consent form prior to the index-procedure
Who cannot join
- Pregnancy
- Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia < 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
- Prior hernia repair at laparotomy site
- Use of planar mesh in addition to sutures for closure
- CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
- Life expectancy less than 1 year
Show all 9Show fewer
- Patient is unable / unwilling to provide informed consent
- Patient is unable to comply with the protocol or proposed follow-up visits
- Patient is enrolled in another abdominal wall study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Frederik Berrevoet, Prof. Dr.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
Read the detailed description
This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.
- Being tested
- Duramesh, Polydioxanone suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurameshDevice
Laparotomy closure with Duramesh
Polydioxanone sutureDevice
Laparotomy closure with standard PDS
| Study group | Role | What they receive |
|---|---|---|
| Duramesh | Other | Laparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction.
Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair.
Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study.
Size 1 Duramesh is used in this RCT. Duramesh is CE-marked. Receives: Device: Duramesh |
| Standard suture | Other | 2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator. Receives: Device: Polydioxanone suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is SSE that occurs within 1 month after surgery.
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month).
SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other
Measured: 1 month
Secondary outcomes (13)
SSE within the first 12 months after repair.
SSE include: Surgical incision wound (this does NOT include a less than 5 mm scar-related superficial wound due to scar instability), Chronic draining sinus, Enterocutaneous fistula, Persistent seroma or fluid collection between the abdominal wall incision and the skin but not draining, Other
Measured: 12 months
Clinical hernia occurrence/recurrence within 12 months after repair.
This study is intended to demonstrate Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
Measured: 12 months
Return to the operating room (re-interventions) within 12 months for device related issue.
Re-interventions are defined as: All re-interventions relating to abdominal wall closure complications or abdominal re-exploration.
Measured: 12 months
Surgeon satisfaction at index-procedure using the 5-point smiley face scale.
Measured: Procedure
Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.
Measured: 1 month
Technical success of index-procedure.
Technical success is defined as successful abdominal wall closure without unexpected difficulties.
Measured: Procedure
Device performance using the 5-point smiley face scale.
Measured: Procedure
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.
The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.
Measured: 1 month
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.
The pain NRS is a single 11-point numeric scale with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondents selects a whole number (0 to 10 integers) that best reflects the intensity of their pain. Pain will be scored in rest and with activity. Activity is defined as activity of daily living, e.g. walking, driving, getting into a car, setting the dinner table, doing the laundry, etc.
Measured: 12 months
Palpability/sensation of suture used for the repair at 12-months follow-up.
Assessment whether the patient can feel the suture.
Measured: 12 months
Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.
The SF-12 Health Survey is a 12-item, patient-reported survey of patient health.
Measured: 12 months
Patient satisfaction at 1-month follow-up 5-point smiley face scale.
Measured: 1 month
Patient satisfaction at 12-months follow-up 5-point smiley face scale.
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 posted7 Apr 2023
- Study start31 Mar 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparotomy Closure After Abdominal SurgeryStudies 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
- Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804136
- Sponsor's protocol ID
- MOMENTUM RCT ONZ-2022-0507
- Acronym
- MOMENTUM RCT
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
- ClinicalTrials.gov ID
- NCT05804136
- Acronym / sponsor ID
- MOMENTUM RCT / MOMENTUM RCT ONZ-2022-0507
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Apr 2023 (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.
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.
Detailed description
This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study
| Arm | Type | Receives |
|---|---|---|
| Duramesh | Other | Device: DurameshLaparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction. Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair. Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study. Size 1 Duramesh is used in this RCT. Duramesh is CE-marked. |
| Standard suture | Other | Device: Polydioxanone suture2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or greater
- Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
- Isolated ostomy site takedown with or without parastomal hernia
- Patient accepts participation and gives informed consent
- Patient and investigator signed and dated the informed consent form prior to the index-procedure
Key exclusion criteria (9 listed)
- Pregnancy
- Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia < 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
- Prior hernia repair at laparotomy site
- Use of planar mesh in addition to sutures for closure
- CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
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 |
|---|---|---|
| DurameshLaparotomy closure with Duramesh | Device | Duramesh |
| Polydioxanone sutureLaparotomy closure with standard PDS | Device | Standard suture |
Primary outcome
The primary outcome is SSE that occurs within 1 month after surgery.
Time frame: 1 month
This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other
13 secondary outcomes
SSE within the first 12 months after repair.
Time frame: 12 months
Clinical hernia occurrence/recurrence within 12 months after repair.
Time frame: 12 months
Return to the operating room (re-interventions) within 12 months for device related issue.
Time frame: 12 months
Surgeon satisfaction at index-procedure using the 5-point smiley face scale.
Time frame: Procedure
Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.
Time frame: 1 month
Technical success of index-procedure.
Time frame: Procedure
Device performance using the 5-point smiley face scale.
Time frame: Procedure
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.
Time frame: 1 month
Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.
Time frame: 12 months
Palpability/sensation of suture used for the repair at 12-months follow-up.
Time frame: 12 months
Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.
Time frame: 12 months
Patient satisfaction at 1-month follow-up 5-point smiley face scale.
Time frame: 1 month
Patient satisfaction at 12-months follow-up 5-point smiley face scale.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes
Related trials for Laparotomy Closure After Abdominal Surgery
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Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
Recruiting
NoPro - Norwegian Hernia Prophylaxis Study
Incisional Hernia After Midline Laparotomy, Quality of Life (QOL)
Not yet recruiting
Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
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Recruiting
Abdominal Wall Closure After Laparotomy in Oncologic Surgery
Laparotomy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duramesh and Polydioxanone suture in people with Laparotomy Closure After Abdominal Surgery, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorien Haesen, PhD (+32 11 28 69 48, dorien.haesen@archerresearch.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is SSE that occurs within 1 month after surgery. (time frame: 1 month). 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 17 Apr 2025.