Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives

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.

• Evaluating wound closure products to close larger surgical site incisions (Device), also known as 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 incisions (Device), also known as 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.

Primary outcomes

• Wound Adhesion Scoring [8-12 weeks post-operation]: Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.

Secondary outcomes

• Dry Time [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.
• Modified Hollander Cosmesis Score (Total Score) [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.
• Participant Satisfaction With Cosmetic Outcome [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.
• Operator Satisfaction Score (1-10 Scale) [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.
• Counts of Surgical Site Infections [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.
• Counts of Inflammatory reactions [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

• Mesh application time [During the procedure]: Time to apply Mesh in seconds
• Glue Application Time [During the procedure]: Time to apply glue

Sex: All, ages: 18 Years to any

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).

• Study Protocol and Statistical Analysis Plan (PDF, 2025-03-13)

• Scott Dupar, Physician - Doctor of Medicine, Principal investigator, Nadora Healthcare