Abstract
BACKGROUND: Soft tissue and cutaneous tension is an important contributor to complicated wound healing and poor scar cosmesis after surgery and its mitigation is a key consideration in aesthetic and reconstructive procedures. OBJECTIVES: The study objective was to assess the efficacy of the force modulating tissue bridge (FMTB) ("Brijjit", Brijjit Medical Inc., Atlanta, GA) in reducing mechanical tension on postoperative wounds. METHODS: A prospective, single-center, randomized, within-subject clinical trial was conducted to evaluate wound healing and nascent scar formation after 8 weeks of postoperative wound support with the FMTB. Patients received standard of care (SOC) subcuticular closure on the vertical incision of 1 breast and experimental closure with the FMTB on the contralateral incision after Wise-pattern reduction mammaplasty. Three-dimensional wound analysis and rates of T-junction dehiscence were evaluated by clinical assessment at 2, 4, 6, and 8 weeks postsurgery. RESULTS: Thirty-four patients (n = 68 breasts) completed 8 weeks of postoperative FMTB application. There was a reduced rate of T-junction wound dehiscence in FMTB breasts (n = 1) vs SOC breasts (n = 11) (P < .01). The mean vertical incision wound area during the intervention period was significantly decreased in the FMTB breast (1.5 cm2) vs the SOC breast (2.1 cm2) (P < .01) and was significantly lower at 2-, 4-, and 8-week follow-up (P < .01). Only the closure method was significantly associated with variations in Week 8 wound area (P < .01) after linear regression modeling. CONCLUSIONS: FMTBs decrease nascent scar dimensions and reduce the occurrence of wound dehiscence. This study provides evidence that the use of continuous mechanomodulation significantly reduces postoperative wound complications after skin closure.