Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives

NCT07613892 | Completed FDA Device

• 1 other identifier: MED-2024-DIV71-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 damage to the skin edges.

Conditions

Wound Closure; Dehisced Surgical Wounds

Keywords

surgical site closure; Wound Closure; wound dehiscence; adhesive performance

Outcome Measures

Primary Outcomes (1)

• Wound Adhesion Scoring

  Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.

  8-12 weeks post-operation

Secondary Outcomes (6)

• Dry Time

  During the procedure

• Modified Hollander Cosmesis Score (Total Score)

  8-12 weeks post-operation

• Participant Satisfaction With Cosmetic Outcome

  8-12 weeks post-operation

• Operator Satisfaction Score (1-10 Scale)

  8-12 weeks post-operation

• Counts of Surgical Site Infections

  8-12 weeks post-operation

Other Outcomes (2)

• Mesh application time

  During the procedure

• Glue Application Time

  During the procedure

Study Arms (2)

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.\[

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

Device: Evaluating wound closure products to close smaller surgical site incisions

Interventions

Evaluating wound closure products to close larger surgical site incisions DEVICE

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.

Also known as: OptiClose, Dermabond

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 incisions DEVICE

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.

Also known as: Opticlose, Dermabond

smaller incisions not requiring mesh are closed using adhesive only with participants randomized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are able to understand and willing to carry out instructions for this study.
• Full thickness surgical incision requiring subcutaneous closure.

You may not qualify if:

• Known sensitivities/allergies to the ingredients contained in the products. Individuals with a self-reported Type IV hypersensitivity reaction to cyanoacrylates (namely acrylates).

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Nadora Healthcare

Johnstown, Colorado, 80534, United States

Location

Study Officials

• Scott Dupar, Physician - Doctor of Medicine

  Nadora Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: study evaluates the use of Medline product compared with a competitor for subcutaneous tissue closure following surgical site incisions.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 29, 2026
• Study Start: April 2, 2025
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)