A Randomized Controlled Trial of the embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation
A Randomized Controlled Trial of the embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation
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DOI：
10.1097/prs.0000000000000417
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发表时间：
2014-09-01
影响因子：
3.6
通讯作者：
Gurtner, Geoffrey C.
中科院分区：
文献类型：
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作者：
Longaker, Michael T.;Rohrich, Rod J.;Gurtner, Geoffrey C.
背景：瘢痕是临床医学中一个重要的生物医学负担。Mechanomodulation已被链接到疤痕通过炎症，但到现在为止，一个系统的方法来减弱机械力，减少疤痕一直不可能的mechanomodulation：作者进行了一项为期12个月的，前瞻性，开放标签，随机，多中心临床试验，以评估腹部手术疤痕外观术后治疗与拥抱先进的疤痕治疗设备，以减少愈合手术切口的机械力。来自65名健康成人受试者的切口被随机分配到接受腹部整形术切口的一半接受拥抱治疗，另一半接受对照治疗（外科医生的最佳护理方法）。本研究的主要终点是使用视觉模拟量表瘢痕score.Results的治疗和对照侧的瘢痕外观的评估之间的差异：最终12个月的研究照片，从36名受试者谁完成了至少5周的敷料应用。在12个月时，与对照治疗的瘢痕（3.29）相比，拥抱治疗瘢痕的平均视觉模拟量表评分（2.90）显著改善（差异，0.39; 95%置信区间，0.14至0.66; p= 0.027）。受试者和研究者均发现，使用患者和观察者瘢痕评估量表评估，接受拥抱治疗的瘢痕在12个月时的总体外观表现出显著改善（分别为p = 0.02和p < 0.001）。结论：这些结果表明，拥抱设备显着减少疤痕腹壁整形手术后。据作者所知，这代表了术后瘢痕减少的第一个I级证据。
Background: Scarring represents a significant biomedical burden in clinical medicine. Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible.Methods: The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions. Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment (surgeon's optimal care methods) on the other half. The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score.Results: Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application. The mean visual analogue scale score for embrace-treated scars (2.90) was significantly improved compared with control-treated scars (3.29) at 12 months (difference, 0.39; 95 percent confidence interval, 0.14 to 0.66; p= 0.027). Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation (p = 0.02 and p < 0.001, respectively). No serious adverse events were reported.Conclusions: These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. To the authors' knowledge, this represents the first level I evidence for postoperative scar reduction.