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含锌透明质酸海绵与安慰剂用于减少乳房手术后瘢痕的临床评估

Clinical Evaluation of Hyaluronic Acid Sponge with Zinc versus Placebo for Scar Reduction after Breast Surgery.

作者信息

Mahedia Monali, Shah Nilay, Amirlak Bardia

机构信息

Department of Plastic Surgery, University of Texas Southwestern School of Medicine, Dallas, Tex.

出版信息

Plast Reconstr Surg Glob Open. 2016 Jul 11;4(7):e791. doi: 10.1097/GOX.0000000000000747. eCollection 2016 Jul.

Abstract

BACKGROUND

Scar formation is a major source of dissatisfaction among patients and surgeons. Individually, hyaluronan, or hyaluronic acid (HA), and zinc have been shown to reduce scarring. The authors evaluated the safety and efficacy of an HA sponge with zinc compared with placebo when applied to bilateral breast surgery scars; specifically, they evaluated whether the use of this product modulates inflammation and immediate scarring in treated patients after bilateral breast surgery.

METHODS

This double-blind, randomized, prospective study was approved by the local institutional review board. Bilateral breast surgery patients with right and left incision lines were randomly assigned to receive HA sponge with zinc or placebo within 2 to 4 days after their procedure. Participants were followed up at 6 weeks, 12 weeks, and 1 year and evaluated at 12 weeks. Three blinded evaluators reviewed photographs of the incision lines and assessed the scars using a visual analog scale, new scale, and a patient satisfaction survey.

RESULTS

Nineteen bilateral breast surgery patients were enrolled in the study. Statistical analysis was performed on 14 patients who completed the follow-up. The mean visual analog scale score was lower for the side receiving the HA sponge with zinc (2.6) than for the side receiving placebo (3.0), indicating a better outcome (t test; P = 0.08). The HA sponge with zinc was found to have significant positive findings on a patient satisfaction survey (P = 0.01).

CONCLUSIONS

This is a preliminary study that shows zinc hyaluronan was associated with high patient satisfaction in achieving a better scar after bilateral breast surgery, irrespective of skin color. It seems to be safe and effective for early scars.

摘要

背景

瘢痕形成是患者和外科医生不满意的主要原因。单独使用透明质酸(HA)和锌已被证明可减少瘢痕形成。作者评估了含锌透明质酸海绵与安慰剂相比,应用于双侧乳房手术瘢痕时的安全性和有效性;具体而言,他们评估了该产品的使用是否能调节双侧乳房手术后治疗患者的炎症和即时瘢痕形成。

方法

本双盲、随机、前瞻性研究已获当地机构审查委员会批准。有左右切口线的双侧乳房手术患者在术后2至4天内被随机分配接受含锌透明质酸海绵或安慰剂。在6周、12周和1年对参与者进行随访,并在12周时进行评估。三名盲法评估者查看切口线照片,并使用视觉模拟量表、新量表和患者满意度调查对瘢痕进行评估。

结果

19例双侧乳房手术患者纳入本研究。对14例完成随访的患者进行了统计分析。接受含锌透明质酸海绵一侧的视觉模拟量表平均得分(2.6)低于接受安慰剂一侧(3.0),表明结果更好(t检验;P = 0.08)。含锌透明质酸海绵在患者满意度调查中发现有显著阳性结果(P = 0.01)。

结论

这是一项初步研究,表明透明质酸锌与双侧乳房手术后获得更好瘢痕的高患者满意度相关,与肤色无关。它似乎对早期瘢痕安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/470c/4977119/ae36d7843fca/gox-4-e791-g001.jpg

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