Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives

Part of paid clinical trials in Johnstown, Colorado.

Sponsor
Medline Industries
Study ID
NCT07613892
Status
Completed

Conditions

  • Dehisced Surgical Wounds
  • Wound Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
May 2026
Primary completion
Mar 18, 2026
Completion
Mar 18, 2026

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: larger incisions requiring mesh are randomized to two a Medline product and the other a comparator
    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.\[
  • Experimental: smaller incisions not requiring mesh are closed using adhesive only with participants randomized
    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

Primary Outcome Measure

Wound Adhesion Scoring [ Time Frame: 8-12 weeks post-operation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nadora HealthcareJohnstownColorado80534-

Find similar trials in Johnstown, CO

By research site
Nadora Healthcare· Johnstown, CO

Related Studies