Evaluation of a novel wound closure device: a multicenter randomized controlled trial
Adam J Singer1, Stuart Chale, Phil Giardano
1Department of Emergency Medicine, Stony Brook University, NY, USA. adam.singer@stonybrook.edu
Objectives:
A novel wound closure device combining a mesh tape and octylcyanoacrylate (OCA) topical skin adhesive (TSA) was developed to facilitate wound closure and enhance the adhesive's strength. The objective of this study was to determine whether the incidence of wound dehiscence after laceration repair with the new device was equivalent to that after use of a high-viscosity OCA. We hypothesized that the rate of complete wound edge apposition would be equivalent for the two closure devices.
Methods:
This was a multicenter, randomized clinical trial in nine academic and community emergency departments (EDs) and urgent care centers. Patients with simple traumatic lacerations were included. Lacerations were randomly closed with a high-viscosity OCA or mesh tape-OCA combination. The rate of complete wound edge apposition at 14 days, rates of wound infection at 14 and 30 days, and the percentage of optimally appearing scars at 30 days after closure were assessed. Assuming a maximal clinically acceptable difference for equivalence of 8% in the rate of completely apposed wound edges, a sample of at least 138 patients in the tape-OCA group and at least 69 in the OCA-only group would give 80% power and a one-sided significance level of 5%.
Results:
During the study period the investigators enrolled 216 subjects, of whom 143 were randomized to the tape-OCA combination and 73 to the OCA-only group. Most wounds were located on the face and the upper extremities. Mean laceration length was similar in patients in both groups (tape-OCA 2.1 cm vs. OCA-only 2.0 cm; difference 0.1 cm, 95% confidence interval [CI] = -0.45 to 0.58 cm). The rate of complete wound edge apposition at 14 days was higher in wounds treated with the tape-OCA combination than in wounds treated with OCA alone (86.0% vs. 78.1%). The upper bound of the one-sided CI was 1.0% for the intention-to-treat population, which was less than the predetermined acceptable difference of less than 8%. There were no between-group differences in rates of infection and optimally appearing scars.
Conclusions:
When compared with OCA alone, the novel tape-OCA combination is equivalent with regard to complete wound edge apposition and cosmetic appearance.
