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OpenTrials
Completed

NCT Number: NCT07613892

Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives

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.

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Key information

Conditions

Wound Closure Dehisced Surgical Wounds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nadora Healthcare

Johnstown, Colorado, 80534, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: OptiClose, Dermabond

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.

Other names: Opticlose, Dermabond

Primary outcomes

  1. Wound Adhesion Scoring

    Time frame: 8-12 weeks post-operation

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

Secondary outcomes

  1. Dry Time

    Time frame: During the procedure

    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.

  2. Modified Hollander Cosmesis Score (Total Score)

    Time frame: 8-12 weeks post-operation

    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.

  3. Participant Satisfaction With Cosmetic Outcome

    Time frame: 8-12 weeks post-operation

    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.

  4. Operator Satisfaction Score (1-10 Scale)

    Time frame: 8-12 weeks post-operation

    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.

  5. Counts of Surgical Site Infections

    Time frame: 8-12 weeks post-operation

    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.

  6. Counts of Inflammatory reactions

    Time frame: 8-12 weeks post-operation

    The counts will be collected of participants experiencing Inflammatory reactions and recorded for each subject as per the ICDRG guidelines.

Other outcomes

  1. Mesh application time

    Time frame: During the procedure

    Time to apply Mesh in seconds

  2. Glue Application Time

    Time frame: During the procedure

    Time to apply glue

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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