Aesthet Surg J. 2023 Nov 16;43(12):1471-1480. doi: 10.1093/asj/sjad285.
Tension on healing wounds increases the risk of dehiscence and poor or pathologic scar formation. Force modulating tissue bridges (FMTBs) represent a new class of wound closure and support devices designed to offload tension on healing wounds to improve wound healing and scar outcomes.
The study was undertaken to assess the efficacy of FMTBs to reduce the risk of wound healing complications in elective breast surgery.
One hundred twenty-two consecutive patients undergoing bilateral aesthetic breast surgery underwent intraoperative placement of FMTBs on the vertical limb closure site. A matched case-control cohort of 121 consecutive patients was established for comparison. Wounds were considered significant if larger than 3 mm in diameter. The primary outcome of breast wounds >3 mm was reported with a relative risk, and all outcomes were framed with number needed to treat.
The control and intervention cohorts had similar demographics, comorbidities, type of operation, and incision pattern utilized. Within the FMTB group, 96.7% (n = 118) patients completed treatment per protocol. Significant wounds occurred in 1.7% (n = 2) of patients in the tissue bridge vs 15.2% (n = 19) in controls on a per patient/per protocol basis (89% reduction, P < .001). Statistically significant improvements were maintained on sensitivity analyses with intention to treat, even when minor wounds were included. There were no complications noted related to FMTBs.
FMTBs are safe and highly effective at reducing the risk of wound formation in elective breast surgery. Results are consistent with sensitivity analyses based on clinical and methodological factors. Further research will assess long-term scar outcomes.
愈合伤口的张力会增加裂开和形成不良或病理性瘢痕的风险。力调节组织桥（FMTB）代表了一类新的伤口闭合和支撑装置，旨在减轻愈合伤口的张力，以改善伤口愈合和瘢痕结局。
本研究旨在评估 FMTB 降低择期乳房手术中伤口愈合并发症风险的效果。
122 例连续接受双侧美容乳房手术的患者术中在垂直皮瓣闭合部位放置 FMTB。为比较建立了 121 例连续患者的匹配病例对照队列。如果伤口直径大于 3 毫米，则认为伤口显著。报告了乳房伤口>3 毫米的主要结局，并以相对风险和需要治疗的人数来表示所有结局。
对照组和干预组的人口统计学特征、合并症、手术类型和切口模式相似。在 FMTB 组中，96.7%（n=118）的患者按方案完成了治疗。在组织桥组中，有 1.7%（n=2）的患者发生显著伤口，而对照组中则有 15.2%（n=19）的患者发生显著伤口（按患者/方案计算减少 89%，P<0.001）。即使包括小伤口，基于意向治疗的敏感性分析仍保持统计学显著改善。未观察到与 FMTB 相关的并发症。
FMTB 安全且非常有效地降低了择期乳房手术中伤口形成的风险。结果与基于临床和方法学因素的敏感性分析一致。进一步的研究将评估长期瘢痕结局。
