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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Nadora Healthcare
Johnstown, Colorado, United States
Wound Adhesion Scoring
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
Time frame: 8-12 weeks post-operation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8-12 weeks post-operation
Counts of Surgical Site Infections
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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.
Time frame: 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.
Time frame: 8-12 weeks post-operation