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富血小板血浆作为结晶酚辅助治疗小儿藏毛窦疾病的前瞻性随机对照试验

Platelet-rich Plasma as an Adjuvant Therapy to Crystallized Phenol in the Treatment of Pediatric Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial.

作者信息

Azizoglu Mustafa, Klyuev Sergey, Kamci Tahsin Onat, Okur Mehmet Hanifi

机构信息

Istanbul Esenyurt Hospital, Department of Pediatric Surgery, Istanbul, Turkey; Istinye University Health Science Faculty, Department of Stem Cell and Tissue Engineering, Istanbul, Turkey; Pediatric Surgery Stem Cell Application Study Group (PESSCA), (On Behalf of "Pediatric Surgery Stem Cell Association"), Istanbul, Turkey.

Pediatric Surgery Stem Cell Application Study Group (PESSCA), (On Behalf of "Pediatric Surgery Stem Cell Association"), Istanbul, Turkey; AO GK "MEDSI", Department of Pediatric Surgery, Moscow, Russian Federation.

出版信息

J Pediatr Surg. 2025 Jan;60(1):161934. doi: 10.1016/j.jpedsurg.2024.161934. Epub 2024 Sep 14.

Abstract

OBJECTIVE

This study aims to evaluate the safety and efficacy of platelet-rich plasma (PRP) as an adjuvant to crystallized phenol (CP) in treating pediatric pilonidal sinus disease (PSD).

METHODS

A single-center randomized controlled trial was conducted at Istanbul Esenyurt Hospital. Eighty-seven patients aged 0-18 were randomly assigned to two groups: the CP group (n = 42) and the CP + PRP group (n = 45). Upon arrival at the clinic, patients began a regimen of manual shaving and, if necessary, laser epilation every 6-8 weeks. For those with pilonidal abscesses, incision, drainage, and antibiotics were given. The treatment area was sterilized and numbed with local anesthesia. Hair removal and curettage were performed, followed by the application of crystallized phenol. In CP + PRP group, PRP injections were also administered. The procedure concluded with wound dressing and thorough disinfection. The study was registered https://clinicaltrials.gov/ (NCT06324656).

RESULTS

The CP + PRP group demonstrated significantly shorter healing times (19.4 ± 7.88 days) compared to the CP group (30.7 ± 12.9 days) (p < 0.001). The cosmetic score was higher in the CP + PRP group (7.42 ± 1.61) than in the CP group (6.11 ± 1.88, p = 0.001). CP + PRP group had lower VAS scores at measured all-time points after applications (p < 0.05 for each). Complications were comparable between the groups, with no significant differences in bleeding, infections, or skin burns (p > 0.05 for each comparison). No difference was found between groups in terms of total complication rate (p = 0.398). The success rate was higher in CP + PRP group (98%; n = 44) compared to CP group (86%; n = 36) (p = 0.039). Recurrence rates were lower in CP + PRP group (2%; n = 1) than CP group (14%; n = 6) (p = 0.039).

CONCLUSION

The autologous PRP injection in pediatric PSD is safe. The addition of PRP to CP treatment for pediatric PSD significantly improves healing time, cosmetic outcomes, and overall success rates without increasing complication rates. This combined approach offers a promising alternative for effective and efficient treatment of PSD in children.

TYPE OF THE STUDY

Randomized controlled trial.

LEVEL OF EVIDENCE

Level I.

摘要

目的

本研究旨在评估富血小板血浆(PRP)作为结晶酚(CP)辅助剂治疗小儿藏毛窦疾病(PSD)的安全性和有效性。

方法

在伊斯坦布尔埃森尤尔特医院进行了一项单中心随机对照试验。87例年龄在0至18岁的患者被随机分为两组:CP组(n = 42)和CP + PRP组(n = 45)。患者到诊所后开始进行手动剃须方案,必要时每6 - 8周进行一次激光脱毛。对于患有藏毛脓肿的患者,进行切开、引流并给予抗生素治疗。治疗区域进行消毒并用局部麻醉剂麻醉。进行毛发去除和刮除,随后应用结晶酚。在CP + PRP组中,还进行了PRP注射。手术最后进行伤口包扎和彻底消毒。该研究已在https://clinicaltrials.gov/注册(NCT06324656)。

结果

与CP组(30.7 ± 12.9天)相比,CP + PRP组的愈合时间显著缩短(19.4 ± 7.88天)(p < 0.001)。CP + PRP组的美容评分(7.42 ± 1.61)高于CP组(6.11 ± 1.88,p = 0.001)。CP + PRP组在每次应用后的所有测量时间点的视觉模拟评分(VAS)均较低(每次比较p < 0.05)。两组之间的并发症相当,在出血、感染或皮肤烧伤方面无显著差异(每次比较p > 0.05)。两组在总并发症发生率方面无差异(p = 0.398)。CP + PRP组的成功率(98%;n = 44)高于CP组(86%;n = 36)(p = 0.039)。CP + PRP组的复发率(2%;n = 1)低于CP组(14%;n = 6)(p = 0.039)。

结论

小儿PSD中自体PRP注射是安全的。在小儿PSD的CP治疗中添加PRP可显著改善愈合时间、美容效果和总体成功率,且不增加并发症发生率。这种联合方法为有效治疗小儿PSD提供了一种有前景的替代方案。

研究类型

随机对照试验。

证据水平

I级。

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