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评价富氧油基凝胶敷料在接受远端尿道下裂手术修复患者中的疗效:一项前瞻性随机临床试验。

Evaluation of efficacy of oxygen-enriched oil-based gel dressing in patients who underwent surgical repair of distal hypospadias: a prospective randomised clinical trial.

机构信息

Division of Pediatric Surgery, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy.

Department of Pharmacy, Federico II University of Naples, Naples, Italy.

出版信息

World J Urol. 2021 Jun;39(6):2205-2215. doi: 10.1007/s00345-020-03419-1. Epub 2020 Aug 27.

Abstract

PURPOSE

This study aimed to evaluate the efficacy of oxygen-enriched oil-based gel dressing on wound healing and postoperative outcome in children who underwent distal hypospadias repair.

METHODS

We included all patients with distal hypospadias, who underwent Snodgrass urethroplasty and preputioplasty over an 18-months period. The patients were randomized in two groups according to the type of medication: oxygen-enriched oil-based gel (G1) and hyaluronic acid cream (G2). After discharge, parents changed the dressing twice a day for 2-3 weeks postoperatively. The patients were evaluated at 7, 14, 21, 30, 60 and 180 postoperative days and thereafter annually.

RESULTS

One-hundred and fourteen patients (median age 18 months) were included in the study and randomized in two groups, each of 57 patients. The wound healing was significantly faster in G1 compared with G2 (p = 0.001). G1 reported significantly higher SWAS and modified HOPE scores compared with G2 (p = 0.001) at all steps of follow-up. No adverse skin reactions occurred. Foreskin dehiscence and re-operations rates were significantly lower in G1 compared with G2 (p = 0.001). Postoperative foreskin retractability was better in G1, with a significantly higher incidence of secondary phimosis in G2 (p = 0.001). The median treatment costs were significantly lower in G1 compared with G2 (p = 0.001).

CONCLUSION

Postoperative dressing using oxygen-enriched oil-based gel was highly effective, promoting a faster wound healing in patients who underwent distal hypospadias repair. It reported a lower incidence of foreskin dehiscence and better foreskin retractability compared with the control group. It was cost-effective and clinically safe without allergy or intolerance to the product.

摘要

目的

本研究旨在评估富氧油基凝胶敷料在接受远端尿道下裂修复术的儿童中的伤口愈合和术后结局的疗效。

方法

我们纳入了在 18 个月期间接受 Snodgrass 尿道成形术和包皮成形术的所有远端尿道下裂患者。根据用药类型将患者随机分为两组:富氧油基凝胶组(G1)和透明质酸乳膏组(G2)。出院后,家长在术后 2-3 周内每天更换两次敷料。患者在术后 7、14、21、30、60 和 180 天以及此后每年进行评估。

结果

本研究共纳入 114 例(中位年龄 18 个月)患者,并随机分为两组,每组 57 例。G1 的伤口愈合明显快于 G2(p=0.001)。G1 在所有随访阶段的 SWAS 和改良 HOPE 评分均显著高于 G2(p=0.001)。未发生不良皮肤反应。G1 的包皮裂开和再次手术率明显低于 G2(p=0.001)。G1 的术后包皮可回缩性更好,G2 的继发性包茎发生率显著更高(p=0.001)。G1 的治疗费用中位数明显低于 G2(p=0.001)。

结论

在接受远端尿道下裂修复术的患者中,术后使用富氧油基凝胶敷料的效果显著,可促进更快的伤口愈合。与对照组相比,G1 报告的包皮裂开发生率较低,包皮可回缩性更好。它具有成本效益,且临床安全性高,无产品过敏或不耐受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4395/8217004/974efd59f0e8/345_2020_3419_Fig1_HTML.jpg

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