A Clinical Evaluation of Efficacy and Safety of Hyaluronan Sponge with Vitamin C Versus Placebo for Scar Reduction

透明质酸海绵联合维生素C与安慰剂治疗疤痕减少的疗效和安全性临床评价

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Abstract

BACKGROUND: Scar formation after injury or surgery is a major clinical problem. Individually, hyaluronan, or hyaluronic acid (HA), and vitamin C have been shown to reduce scarring by means of different mechanisms. The authors evaluated the efficacy and safety of an HA sponge system containing an active derivative of vitamin C to determine whether the use of this product promotes healing and reduces inflammation and scarring after surgery. METHODS: This double-blind, randomized, prospective study was approved by the local institutional review board. Participants who had unilateral or bilateral surgical scars more than 1 month but less than 18 months old were enrolled. Surgical scars were randomly assigned to receive placebo or HA sponge with vitamin C. Three blinded evaluators reviewed photographs of the incision lines and assessed the scars using a visual analog scale. A patient satisfaction survey was also administered. Participants were followed up at 4 weeks, 12 weeks, and 1 year. RESULTS: Twenty-three patients were enrolled in the study. Six patients dropped out of the study, for a total of 17 patients included in final analysis. Mean (range) age of patient was 43.5 (25-67) years. Mean (range) body mass index was 27.4 (18-36.9) kg/m(2). The mean visual analog scale score for scars receiving HA sponge with vitamin C was slightly lower than the scars receiving placebo, but the difference was not statistically significant (t test; P = 0.9). The HA sponge with vitamin C was found to have significant positive findings on a patient satisfaction survey. CONCLUSIONS: The HA sponge system with vitamin C is safe to use in any scars older than 4 weeks. It has high patient satisfaction in achieving a better scar after surgery. The micro-roller used to apply the product was easy to use to potentially increase the spread of the medication in older scars.

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