Casas Laurie A, Claytor R Brannon, Zeidler Kamakshi R, Shridharani Sachin M, Cohen Steven R, Khanna Julie J, Gould Daniel J, Yates Essie K, Lultschik Shantel, Bell Michaela, Widgerow Alan D
Section of Plastic & Reconstructive Surgery, The University of Chicago Medicine, Chicago, IL, USA.
Division of Plastic Surgery, Main Line Health Systems, Bryn Mawr, PA, USA.
Aesthet Surg J Open Forum. 2022 Jun 10;4:ojac054. doi: 10.1093/asjof/ojac054. eCollection 2022.
Skin preconditioning prior to and following procedures, has previously been demonstrated to hasten and optimize healing, and decrease the symptoms and signs associated with invasive surgery. These trials involved the use of multiple topical products. In an effort to control costs and to increase patient compliance, a single surgical product was developed, with actives aimed at decreasing swelling, bruising, induration, and internal fibrous banding.
This multi-center trial was designed to measure the efficacy of this single product in these mentioned parameters.
A double-blind, randomized, split body, clinical study was undertaken in 29 patients involving 38 surgical procedures. Assessments included photography, biopsies, ultrasound imaging, and blinded investigator and participant assessments.
Differentiated results between test comparator sides became apparent at postop day 10-14 (as previously observed). Thus, blinded investigator and participant assessment scores demonstrated statistical significance exclusive to the test product side at postop day 10-14 for ecchymoses and then extending to skin discoloration, edema, induration and subcutaneous fibrous banding, at weeks 3, 4, 6, and 12. Ultrasound evaluation confirmed the earlier dissolution of fibrous banding on the test side in the subcutaneous tissue at the 3-6-week postop period. In addition, biopsies assessing the pre-conditioned period prior to surgery confirmed that the topical test product stimulated a remodeled extracellular matrix without comparative changes on the opposite side.
A single peri-surgical product designed for the use with invasive surgery produced significant differences in ecchymosis, skin discoloration, edema, induration and ongoing resolution of fibrous banding over many weeks. This study validation provides an additional adjunct to surgical procedures.
此前已有研究表明，在手术前后进行皮肤预处理可加速并优化愈合过程，减轻与侵入性手术相关的症状和体征。这些试验使用了多种外用产品。为控制成本并提高患者依从性，研发了一种单一的手术产品，其活性成分旨在减轻肿胀、瘀伤、硬结和内部纤维条索形成。
本多中心试验旨在测量该单一产品在上述参数方面的疗效。
对29例患者进行了涉及38项手术的双盲、随机、分体临床研究。评估包括摄影、活检、超声成像以及盲法研究者和参与者评估。
在术后第10 - 14天（如先前观察到的），测试组与对照组之间的差异结果变得明显。因此，盲法研究者和参与者评估分数显示，在术后第10 - 14天，测试产品组在瘀斑方面具有统计学意义，随后在第3、4、6和12周扩展至皮肤变色、水肿、硬结和皮下纤维条索形成。超声评估证实，在术后3 - 6周，测试侧皮下组织中的纤维条索更早溶解。此外，评估手术前预处理期的活检证实，局部测试产品刺激了细胞外基质重塑，而对侧无相应变化。
一种专为侵入性手术设计的单一围手术期产品在瘀斑、皮肤变色、水肿、硬结以及数周内纤维条索的持续消退方面产生了显著差异。本研究验证为手术操作提供了额外的辅助手段。
