Evaluation of a new skin closure device in surgical incisions associated with breast procedures.

Background: A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner. To determine its clinical utility in breast procedures, a prospective clinical investigation was undertaken to demonstrate equivalence of a newadhesive (PRINEO (TM) Skin Closure System) to intradermal sutures in wound closure. Methods: The investigation comprised 79 patients who underwent elective surgery for bilateral breast procedures. Each breast incision was randomized to wound closure with the PRINEO (TM) Skin Closure System or intradermal sutures (used in accordance with standard local practice). Postoperative evaluations took place at 24 hours, 7 days, 12-25 days, 90 days, 6 months, and 12 months. Data were collected on the continuous approximation of the skin edges, the time required to close the include final skin layer, the evaluation of incision healing, and cosmesis outcomes. Safety evaluations were related to the incidence and extent of local acute inflammatory reactions, clinical infection, skin blistering, and adverse events. Results: PRINEO (TM) Skin Closure System was found to be equivalent to intradermal sutures for the continuous approximation of wounds associated with breast procedures. The upper limit of the one-sided 95% confidence interval for difference in proportions was less than the predetermined 12%, at 5.9%. The mean time to closure for the PRINEO (TM) Skin Closure System was 2.56 minutes, which was 13.66 minutes faster than that for intradermal sutures (16.22 minutes, P < 0.0001). Time savings may be less if 2 operators close simultaneously. On the other hand, because the device can be applied by 1 operator, the assistant's time may be freed up to attend to other tasks. Both treatments had similar incision healing and cosmetic outcomes. No quantitative or qualitative differences of clinical significance were evident between the treatment groups for local acute inflammatory reactions, clinical infection, or skin blistering. The number of serious adverse events was low, although the number of adverse events was higher, with 54/79 patients experiencing at least 1 adverse event. Conclusion: PRINEO (TM) Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions associated with breast procedures, with regard to safety and effectiveness. It was also 6.3 times faster than intradermal sutures for wound closure.