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临床试验/NCT06324656
NCT06324656招募中不适用

The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease Treatment in Children: A Double-blind Single-center Randomized Controlled Trial

Necmi Kadıoğlu Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Average time to full daily activities

研究概览

简要总结

The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients.

详细描述

Upon their arrival at our pilonidal care clinic, patients commenced a regimen of manual shaving of the gluteal cleft either weekly or bi-weekly. Laser epilation therapy was initiated at the earliest opportunity, conducted every 6 to 8 weeks, aiming for a hair reduction of over 90%. For patients presenting with a pilonidal abscess, an initial procedure of incision and drainage was performed, followed by antibiotic therapy. In the outpatient clinic, patients were placed in a prone position, and the area was sterilized with a povidone-iodine solution.

Anaesthesia local: The skin and subcutaneous tissues surrounding the PSD area, including the sinus openings, receive local anesthesia with 5 ml of lidocaine (20 mg/ml) mixed with epinephrine (0.0125 mg/ml).

Zone keeps clean: The area surrounding the PSD is thoroughly disinfected with povidone-iodine solution, covering a minimum area of 20 square centimeters to ensure adequate local disinfection.

Irrigation with isotonic solution: The wound is washed with sterile isotonic solution.

Zero hair (removing hair and curettage): For sinuses measuring ≤ 3 mm in diameter, dilation is performed using a mosquito clamp (BH-109, Aesculap®, Center Valley, PA, USA). Hair within the sinus is removed. After the complete removal of hair from the area, the granulation tissue is then excised through curettage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The study will be included patients with pilonidal sinus disease aged between 0 to 18 years.

排除标准

  • Patients who had undergone prior pilonidal sinus disease surgery or had anomalies in the sacrococcygeal region will be excluded from the study. Additionally, patients who will decline to participate in the study or will be failed to attend post-procedural outpatient follow-ups will also be excluded.

结局指标

主要结局

Average time to full daily activities

时间窗: 1 week

It refers to the time when patients return to their routine lives after the procedure.

Healing time

时间窗: 7 weeks

It refers to the wound healing time of the patients after the procedure.

Cosmetic score

时间窗: 7 weeks

All patients will be assessed for cosmetic score after healing. For cosmetic evaluation, observers were asked to assess the scar in comparison to normal skin by answering the question, "What is your overall opinion of the scar compared to normal skin?" They rated the scar on a scale from 1 to 10, where 10 signifies normal skin and 1 represents a very different, worst possible scar.

VAS scores

时间窗: 2 weeks

Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days following the procedure.

Success rate

时间窗: 7 weeks

The succes rate will be calculated after interventions

Recurrence rate

时间窗: 7 weeks

The recurrence rate will be calculated after interventions

次要结局

  • Total complication rate(7 weeks)
  • Bleeding rate(1 week)
  • Infection rate(7 weeks)
  • Skin burn rate(7 weeks)

研究者

发起方
Necmi Kadıoğlu Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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