Randomized Study of a New Noninvasive Skin Closure Device for Use After Congenital Heart Operations

Abstract

We report a new, noninvasive Zip surgical skin closure device (ZipLine Medical, Campbell, CA). This device is considered to have good cosmetic outcomes after operations and reduces surgical time. In this study, skin closure using the Zip device was compared with subcuticular sutures and the usefulness and safety of this new device was evaluated. This was a prospective, randomized study of 214 patients who underwent cardiac operations through a median sternotomy from June 2014 to December 2015. In 136 patients, this was a first operation group of which 71 patients underwent Zip surgical skin closure (Zip group), and 65 patients underwent subcuticular sutures (suture group). In 78 patients, this was a reoperation group, of which 42 patients were in the Zip group and 36 patients were in the suture group. Cosmetic results using the Vancouver Scar Scale were evaluated separately in the first operation group and reoperation group. There were significant differences in the total Vancouver Scar Scale score between the first operation group (p < 0.001) and reoperation group (p= 0.007). The skin closure time was significantly shorter in the Zip group than in the suture group (113.0 ± 9.1 seconds vs 375.9 ± 60.2 seconds, p < 0.001). No significant differences were found regarding the rate of surgical site infection between the groups. Complications peculiar to this device included skin discoloration (0.9%), epidermolysis (0.9%), and exfoliation of the device (1.8%); however, no serious complications developed. In congenital heart operations through a median sternotomy, the Zip surgical skin closure device was an excellent choice for improving the cosmetic appearance and reducing the wound closure time. In addition, it proved to be a device that could be used safely.