Wound ClosureNCT07613892
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
A study testing Evaluating wound closure products to close larger surgical site incisions and Evaluating wound closure products to close smaller surgical site incisions in people with Wound Closure and Dehisced Surgical Wounds, run by Medline Industries at 1 site in United States.
Trial summary
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples. Because these products do not require stitching deep into the skin, they can reduce the time it takes to close a wound and may reduce stress or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure, Dehisced Surgical Wounds
- What is being tested?
- Evaluating wound closure products to close larger surgical site incisions and Evaluating wound closure products to close smaller surgical site incisions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to 18 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are able to understand and willing to carry out instructions for this study.
- Full thickness surgical incision requiring subcutaneous closure.
Who cannot join
- Known sensitivities/allergies to the ingredients contained in the products. Individuals with a self-reported Type IV hypersensitivity reaction to cyanoacrylates (namely acrylates).
Trial locations and contacts
1 site in 1 country.
About this study
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples. Because these products do not require stitching deep into the skin, they can reduce the time it takes to close a wound and may reduce stress or damage to the skin edges.
Read the detailed description
The OptiClose surgical adhesive system combines a liquid adhesive with a self-adhering mesh for the closure of surgical incisions and simple lacerations. It acts as a demonstrated noninvasive alternative to skin sutures and staples.
The OptiClose and Dermabond topical skin adhesives combine a self-adhering, pressure sensitive adhesive (PSA), polyester-based mesh (for incisions requiring a mesh), as well as a simple non mesh application system (for incisions that do not require a mesh) for temporarily adjoining the approximated skin edges of an incision, and a 2-octyl cyanoacrylate liquid adhesive formulation for final skin closure. By sparing long intracutaneous sutures, wound closure time is significantly reduced and wound edge ischemia potentially diminished. The purpose of this study is to conduct a two arm, prospective, randomized control trial by which participants will be randomly assigned to either receive the Dermabond wound closure adhesive or the OptiClose wound closure adhesive in participants undergoing the closure of any subcutaneous tissue following surgical site incisions.
- Conditions
- Wound Closure, Dehisced Surgical Wounds
- Being tested
- Evaluating wound closure products to close larger surgical site incisions, Evaluating wound closure products to close smaller surgical site incisions
- Keywords
- surgical site closure, Wound Closure, wound dehiscence, adhesive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluating wound closure products to close larger surgical site incisionsDevice
Also called OptiClose, Dermabond
Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics. Incisions requiring mesh support (>20 cm) are closed with adhesive plus mesh using one of the assigned products.
Evaluating wound closure products to close smaller surgical site incisionsDevice
Also called Opticlose, Dermabond
Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics. Incisions not requiring mesh (≤19 cm) are closed using cyanoacrylate-based adhesive alone. Product assignment is randomized within each incision category.
| Study group | Role | What they receive |
|---|---|---|
| larger incisions requiring mesh are randomized to two a Medline product and the other a comparator | Experimental | In the first arm, larger incisions (greater than 20cm) requiring mesh are randomized to either OptiClose Secure or Dermabond Prineo. Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits. Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application. Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise. The study involved an overall duration of approximately 4-6 months[SR1] [NS2] , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window.[ Receives: Device: Evaluating wound closure products to close larger surgical site incisions |
| smaller incisions not requiring mesh are closed using adhesive only with participants randomized | Experimental | In the second arm, smaller incisions (19 cm or smaller) not requiring mesh are closed using cyanoacrylate-based adhesive ("glue") only, with participants randomized to OptiClose Rapid or Dermabond Advanced. Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits. Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application. Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise. The study involved an overall duration of approximately 4-6 months. , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window Receives: Device: Evaluating wound closure products to close smaller surgical site incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Adhesion Scoring
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
Measured: 8-12 weeks post-operation
Secondary outcomes (6)
Dry Time
Timing in seconds to start once the applicator has contacted the skin and ends when the application of the liquid adhesive is complete and is no longer wet to the touch.
Measured: During the procedure
Modified Hollander Cosmesis Score (Total Score)
Cosmetic appearance of the wound as identified by the Modified Hollander Wound Evaluation Scale. The Modified Hollander Cosmesis Scale consists of multiple components assessed as binary outcomes (1 = absence, 0 = presence). Individual item scores are summed to generate a total score per participant (overall cosmesis score) The total score ranges from 1 to 6, with higher scores indicating better cosmetic outcome.
Measured: 8-12 weeks post-operation
Participant Satisfaction With Cosmetic Outcome
Participant satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction. This assessment was collected alongside the Modified Hollander cosmesis evaluation.
Measured: 8-12 weeks post-operation
Operator Satisfaction Score (1-10 Scale)
Operator satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction. This assessment was collected alongside the Modified Hollander cosmesis evaluation.
Measured: 8-12 weeks post-operation
Counts of Surgical Site Infections
The counts will be collected of participants experiencing surgical site infections (SSIs) and recorded for each subject (as occurring within 30 days of treatment) as per the CDC guidelines.
Measured: 8-12 weeks post-operation
Counts of Inflammatory reactions
The counts will be collected of participants experiencing Inflammatory reactions and recorded for each subject as per the ICDRG guidelines.
Measured: 8-12 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Apr 2025
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ClosureStudies 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
- Single group
- Model description
- study evaluates the use of Medline product compared with a competitor for subcutaneous tissue closure following surgical site incisions.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Dupar, Physician - Doctor of Medicine, Principal investigator, Nadora Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613892
- Sponsor's protocol ID
- MED-2024-DIV71-003
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
- ClinicalTrials.gov ID
- NCT07613892
- Acronym / sponsor ID
- MED-2024-DIV71-003
- Conditions
- Wound Closure, Dehisced Surgical Wounds
- Keywords
- surgical site closure, Wound Closure, wound dehiscence, adhesive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 29 May 2026 (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.
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples. Because these products do not require stitching deep into the skin, they can reduce the time it takes to close a wound and may reduce stress or damage to the skin edges.
Detailed description
The OptiClose surgical adhesive system combines a liquid adhesive with a self-adhering mesh for the closure of surgical incisions and simple lacerations. It acts as a demonstrated noninvasive alternative to skin sutures and staples.
The OptiClose and Dermabond topical skin adhesives combine a self-adhering, pressure sensitive adhesive (PSA), polyester-based mesh (for incisions requiring a mesh), as well as a simple non mesh application system (for incisions that do not require a mesh) for temporarily adjoining the approximated skin edges of an incision, and a 2-octyl cyanoacrylate liquid adhesive formulation for final skin closure. By sparing long intracutaneous sutures, wound closure time is significantly reduced and wound edge ischemia potentially diminished. The purpose of this study is to conduct a two arm, prospective, randomized control trial by which participants will be randomly assigned to either receive the Dermabond wound closure adhesive or the OptiClose wound closure adhesive in participants undergoing the closure of any subcutaneous tissue following surgical site incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study evaluates the use of Medline product compared with a competitor for subcutaneous tissue closure following surgical site incisions.
| Arm | Type | Receives |
|---|---|---|
| larger incisions requiring mesh are randomized to two a Medline product and the other a comparator | Experimental | Device: Evaluating wound closure products to close larger surgical site incisionsIn the first arm, larger incisions (greater than 20cm) requiring mesh are randomized to either OptiClose Secure or Dermabond Prineo. Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits. Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application. Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise. The study involved an overall duration of approximately 4-6 months[SR1] [NS2] , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window.[ |
| smaller incisions not requiring mesh are closed using adhesive only with participants randomized | Experimental | Device: Evaluating wound closure products to close smaller surgical site incisionsIn the second arm, smaller incisions (19 cm or smaller) not requiring mesh are closed using cyanoacrylate-based adhesive ("glue") only, with participants randomized to OptiClose Rapid or Dermabond Advanced. Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits. Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application. Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise. The study involved an overall duration of approximately 4-6 months. , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are able to understand and willing to carry out instructions for this study.
- Full thickness surgical incision requiring subcutaneous closure.
Key exclusion criteria (1 listed)
- Known sensitivities/allergies to the ingredients contained in the products. Individuals with a self-reported Type IV hypersensitivity reaction to cyanoacrylates (namely acrylates).
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 |
|---|---|---|
| Evaluating wound closure products to close larger surgical site incisionsAlso: OptiClose, DermabondParticipants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics. Incisions requiring mesh support (>20 cm) are closed with adhesive plus mesh using one of the assigned products. | Device | larger incisions requiring mesh are randomized to two a Medline product and the other a comparator |
| Evaluating wound closure products to close smaller surgical site incisionsAlso: Opticlose, DermabondParticipants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics. Incisions not requiring mesh (≤19 cm) are closed using cyanoacrylate-based adhesive alone. Product assignment is randomized within each incision category. | Device | smaller incisions not requiring mesh are closed using adhesive only with participants randomized |
Primary outcome
Wound Adhesion Scoring
Time frame: 8-12 weeks post-operation
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
6 secondary outcomes
Dry Time
Time frame: During the procedure
Modified Hollander Cosmesis Score (Total Score)
Time frame: 8-12 weeks post-operation
Participant Satisfaction With Cosmetic Outcome
Time frame: 8-12 weeks post-operation
Operator Satisfaction Score (1-10 Scale)
Time frame: 8-12 weeks post-operation
Counts of Surgical Site Infections
Time frame: 8-12 weeks post-operation
Counts of Inflammatory reactions
Time frame: 8-12 weeks post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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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.
Scott Dupar, Physician - Doctor of Medicine principal investigator
Nadora Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluating wound closure products to close larger surgical site incisions and Evaluating wound closure products to close smaller surgical site incisions in people with Wound Closure and Dehisced Surgical Wounds, run by Medline Industries at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 May 2026. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound Adhesion Scoring (time frame: 8-12 weeks post-operation). 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 29 May 2026.