Esposito Ciro, Coppola Vincenzo, Del Conte Fulvia, Cerulo Mariapina, Esposito Giovanni, Crocetto Felice, Castagnetti Marco, Calignano Antonio, Escolino Maria
Division of Pediatric Surgery, Federico II University of Naples, Naples, Italy.
Department of Pharmacy, Federico II University of Naples, Naples, Italy.
Front Pediatr. 2021 Mar 2;9:638406. doi: 10.3389/fped.2021.638406. eCollection 2021.
This study was the second part of a prospective randomized clinical trial and aimed to evaluate the use of a tubular finger oxygen-enriched oil inside-coated dressing device and its effect on the post-operative outcome of children undergoing distal hypospadias repair. A prospective single-blinded randomized clinical trial was carried out between September 2019 and September 2020. We included all patients with distal hypospadias, who received Snodgrass urethroplasty and preputioplasty. The patients were randomized in two groups according to the type of dressing: tubular finger oxygen-enriched oil inside-coated device (G1) and elastic net bandage with application of oxygen-enriched oil-based gel (G2). The patients were evaluated at 7, 14, 21, 30, and 60 post-operative day (POD). Sixty-four patients (median age 14 months) were included in the study and randomized in two groups, each of 32 patients. Post-operative preputial edema rate was significantly lower in G1 (3/32, 9.3%) compared with G2 (10/32, 31.2%) ( = 0.001). The median duration of preputial edema was significantly shorter in G1 compared with G2 (6 vs. 10.5 days) ( = 0.001). Penile diameter measurements at 4th, 7th, 14th POD proved that entity and duration of post-operative swelling were objectively decreased using the new dressing. The wound healing was significantly faster in G1 compared with G2 (14.2 vs. 18.5 days) ( = 0.001). The post-operative complications rate was significantly lower in G1 (0%) compared with G2 (3/32, 9.3%) ( = 0.001). Foreskin dehiscence occurred in two G2 patients (6.2%) whereas, breakdown of urethroplasty and preputioplasty occurred in one G2 patient (3.1%) due to scratching injuries. The dressing management was subjectively assessed by nurses to be easier in G1 patients compared with G2 ones (median score 1.2 vs. 3.5) ( = 0.001). The median treatment costs were significantly lower in G1 compared with G2 (55 vs. 87 eur) ( = 0.001). No adverse skin reactions occurred. Post-operative dressing using tubular finger oxygen-enriched oil inside-coated device was highly effective, easy to manage, cheaper and associated with a lower rate of foreskin and urethral complications compared with the standard dressing method in pediatric patients undergoing distal hypospadias repair. It was also clinically safe without allergy or intolerance to the product.
本研究是一项前瞻性随机临床试验的第二部分，旨在评估一种管状手指富氧油内涂层敷料装置的使用及其对远端尿道下裂修复术后患儿结局的影响。2019年9月至2020年9月进行了一项前瞻性单盲随机临床试验。我们纳入了所有接受Snodgrass尿道成形术和包皮成形术的远端尿道下裂患者。根据敷料类型将患者随机分为两组：管状手指富氧油内涂层装置组（G1）和应用富氧油基凝胶的弹性网绷带组（G2）。在术后第7、14、21、30和60天对患者进行评估。64例患者（中位年龄14个月）纳入研究并随机分为两组，每组32例。G1组术后包皮水肿发生率（3/32，9.3%）显著低于G2组（10/32，31.2%）（P = 0.001）。G1组包皮水肿的中位持续时间显著短于G2组（6天对10.5天）（P = 0.001）。术后第4、7、14天的阴茎直径测量结果证明，使用新敷料可客观降低术后肿胀的程度和持续时间。G1组伤口愈合明显快于G2组（14.2天对18.5天）（P = 0.001）。G1组术后并发症发生率（0%）显著低于G2组（3/32，9.3%）（P = 0.001）。G2组有2例患者发生包皮裂开（6.2%），1例患者因抓伤发生尿道成形术和包皮成形术失败（3.1%）。护士主观评估G1组患者的敷料管理比G2组更容易（中位评分1.2对3.5）（P = 0.001）。G1组的中位治疗费用显著低于G2组（55欧元对87欧元）（P = 0.001）。未发生不良皮肤反应。与接受远端尿道下裂修复术的儿科患者的标准敷料方法相比，使用管状手指富氧油内涂层装置进行术后敷料具有高效、易于管理、成本较低且包皮和尿道并发症发生率较低的特点。该方法在临床上也是安全的，对产品无过敏或不耐受。
