Suture; Complications, MechanicalNCT03940560
Mesh Suture for Internal Load Bearing Closures
A study testing Duramesh Suturable Mesh in people with Suture; Complications, Mechanical and Suture; Complications, Infection or Inflammation, run by Wigmore Clinic at 1 site in Armenia.
Trial summary
Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Suture; Complications, Mechanical, Suture; Complications, Infection or Inflammation, Suture, Complication
- What is being tested?
- Duramesh Suturable Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteArmenia
- Study dates
- 1 Jul 2018to 31 Dec 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deep orthopedic soft tissue approximation
Who cannot join
- Pregnancy
- Age less than 1 year old
- Repair of skin or other epithelial surfaces
- Poor subcutaneous tissues
- Ongoing infection
Trial locations and contacts
1 site in 1 country.
About this study
Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs
Read the detailed description
Sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. When tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. The hernia rate after primary laparotomy depends on the patient population, but is over 10%. In some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. In primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. Mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs.
A novel mesh suture, designed at Northwestern University (Chicago, IL) by Dr. Gregory Dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. Dr. Dumanian has employed the concept of using a mesh-like suture already in his clinical practice. He has cut strips from an FDA-approved piece of hernia mesh, and used them as sutures, tying them with knots.
Based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, Dr. Dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. These are internal permanent sutures and will not be removed. They are made of the identical material (polypropylene) used in standard sutures.
Mesh Sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. Tissue ingrowth around the filaments and into the suture improves their hold.
- Conditions
- Suture; Complications, Mechanical, Suture; Complications, Infection or Inflammation, Suture, Complication
- Being tested
- Duramesh Suturable Mesh
- Keywords
- suture, suture pull-through, suture sinus
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duramesh Suturable MeshDevice
Use of Duramesh Suturable Mesh for internal load bearing closures
| Study group | Role | What they receive |
|---|---|---|
| Duramesh Suturable Mesh | Experimental | Use of Duramesh Suturable Mesh for internal load bearing closures Receives: Device: Duramesh Suturable Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery healing complication, acute
Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure
Measured: 30 days
Secondary outcomes (1)
Surgery healing complication, delayed
Number of patients with infection, drainage, seroma, wound disruption, sinus over the mesh suture closure
Measured: Within 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 May 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: No clinical need to perform study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture; Complications, MechanicalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Safety and efficacy study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wigmore Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garen Koloyan, MD PhD, Principal investigator, Wigmore Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940560
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Suture for Internal Load Bearing Closures
- ClinicalTrials.gov ID
- NCT03940560
- Acronym / sponsor ID
- 001
- Conditions
- Suture; Complications, Mechanical, Suture; Complications, Infection or Inflammation, Suture, Complication
- Keywords
- suture, suture pull-through, suture sinus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No clinical need to perform study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wigmore ClinicUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2019 (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.
Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs
Detailed description
Sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. When tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. The hernia rate after primary laparotomy depends on the patient population, but is over 10%. In some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. In primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. Mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs.
A novel mesh suture, designed at Northwestern University (Chicago, IL) by Dr. Gregory Dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. Dr. Dumanian has employed the concept of using a mesh-like suture already in his clinical practice. He has cut strips from an FDA-approved piece of hernia mesh, and used them as sutures, tying them with knots.
Based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, Dr. Dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. These are internal permanent sutures and will not be removed. They are made of the identical material (polypropylene) used in standard sutures.
Mesh Sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. Tissue ingrowth around the filaments and into the suture improves their hold.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety and efficacy study
| Arm | Type | Receives |
|---|---|---|
| Duramesh Suturable Mesh | Experimental | Device: Duramesh Suturable MeshUse of Duramesh Suturable Mesh for internal load bearing closures |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Deep orthopedic soft tissue approximation
Key exclusion criteria (5 listed)
- Pregnancy
- Age less than 1 year old
- Repair of skin or other epithelial surfaces
- Poor subcutaneous tissues
- Ongoing infection
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 Suturable MeshUse of Duramesh Suturable Mesh for internal load bearing closures | Device | Duramesh Suturable Mesh |
Primary outcome
Surgery healing complication, acute
Time frame: 30 days
Number of patients with infection, drainage, seroma, wound disruption over the mesh suture closure
1 secondary outcome
Surgery healing complication, delayed
Time frame: Within 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 15 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Suture; Complications, Mechanical
Recruiting
Influence of Suture Type on Emergency Midline Laparotomy Closure
Linea Alba Hernia, Evisceration; Operation Wound
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.
Garen Koloyan, MD PhD principal investigator
Wigmore Clinic
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 Suturable Mesh in people with Suture; Complications, Mechanical and Suture; Complications, Infection or Inflammation, run by Wigmore Clinic at 1 site in Armenia.
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 1 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 15 Dec 2023. 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 Armenia. 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?
Surgery healing complication, acute (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 15 Dec 2023.