An interventional study of Evaluating wound closure products to close larger surgical site incisions and Evaluating wound closure products to close smaller surgical site incisions in Wound Closure and Dehisced Surgical Wounds, sponsored by Medline Industries. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Medline Industries · Not applicable, Interventional, and Treatment
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's enrollment of 60 is close to the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
Mesh application time
Time to apply Mesh in seconds
Time frame: During the procedure
Glue Application Time
Time to apply glue
Time frame: During the procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2025 to primary completion in Mar 2026, 11 months.
Of 27 industry-sponsored interventional studies with no phase under Surgical Wound, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 11 months is close to that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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