Evaluation of a novel wound closure device: a multicenter randomized controlled trial

Area of Science:

• Dermatology
• Wound Care
• Medical Devices

Background:

• Topical skin adhesives (TSAs) like octylcyanoacrylate (OCA) are widely used for wound closure.
• Enhancing the adhesive strength and reliability of TSAs is an ongoing area of research.
• A novel wound closure device integrating mesh tape with OCA was developed to improve performance.

Purpose of the Study:

• To evaluate the efficacy of a novel mesh tape-OCA combination for laceration repair.
• To determine if this new device is equivalent to high-viscosity OCA alone in preventing wound dehiscence.
• To compare complete wound edge apposition rates between the two closure methods.

Main Methods:

• A multicenter, randomized clinical trial was conducted across nine emergency departments and urgent care centers.
• Patients with simple traumatic lacerations were randomized to receive closure with either high-viscosity OCA or the mesh tape-OCA combination.
• Outcomes assessed included complete wound edge apposition at 14 days, infection rates at 14 and 30 days, and scar appearance at 30 days.

Main Results:

• A total of 216 subjects were enrolled; 143 received the tape-OCA combination and 73 received OCA alone.
• Complete wound edge apposition at 14 days was higher with the tape-OCA combination (86.0%) compared to OCA alone (78.1%).
• The difference in apposition rates was within the predefined equivalence margin, and no significant differences in infection or scar appearance were observed between groups.

Conclusions:

• The novel mesh tape-OCA combination is equivalent to high-viscosity OCA alone for complete wound edge apposition in laceration repair.
• The new device offers comparable cosmetic outcomes to standard OCA treatment.
• This combination device presents a viable alternative for wound closure, potentially enhancing adhesive strength and reliability.