Effect of Phenol Addition to Laser Treatment on Epithelialization and Healing Process in Pilonidal Sinus: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time to Complete Epithelialization
研究概览
简要总结
This study compares two treatment approaches for pilonidal sinus disease: laser treatment alone versus laser treatment combined with phenol application. Pilonidal sinus is a common condition that affects young adults and can cause significant discomfort and time off work.
Participants will be randomly assigned to receive either laser treatment only (Group A) or laser treatment plus phenol application (Group B). Both treatments are minimally invasive and performed under local anesthesia as day surgery procedures.
The main goal is to determine if adding phenol to laser treatment speeds up the healing process (epithelialization) and improves patient outcomes. We will measure healing time, pain levels, return to daily activities, and quality of life over a 3-month follow-up period.
This research may help develop more effective treatment protocols that reduce healing time and improve patient comfort for people with pilonidal sinus disease.
详细描述
This prospective randomized controlled clinical trial investigates whether adding crystallized phenol to laser treatment improves epithelialization and healing outcomes in patients with pilonidal sinus disease. The study will be conducted at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.
Study Design: 130 patients meeting inclusion criteria will be randomly assigned using computer randomization to two treatment groups (65 patients each):
Group A: Laser treatment only using SiLaC (Sinus Laser Closure) technique Group B: Combined phenol application followed by laser treatment
Treatment Procedures:
Group A receives local anesthesia, pilonidal sinus area cleaning, assessment of sinus openings, and laser probe application into sinus channels.
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
- None
盲法说明
Open-label study due to the nature of surgical interventions which cannot be blinded to participants or care providers
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Primary pilonidal sinus disease
- •Three or fewer pit counts
- •Willing to participate in the study and signed informed consent form
- •Able to attend follow-up visits
排除标准
- •Age under 18 years
- •More than three pit counts
- •Acute abscess presentation
- •Bilateral lateral extension
- •Recurrent pilonidal sinus disease
- •Immunocompromised patients
- •Patients unable to attend follow-up visits
- •Pregnancy (if applicable)
- •Severe comorbidities that contraindicate surgery under local anesthesia
研究组 & 干预措施
Laser Treatment Only
Participants receive laser treatment (SiLaC - Sinus Laser Closure) under local anesthesia. The pilonidal sinus area is cleaned, sinus openings are evaluated, and laser probe is inserted into sinus channels for ablation. Standard post-operative wound care is provided with same-day discharge.
干预措施: Laser Treatment (Procedure)
Crystallized Phenol
Participants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge.
干预措施: Laser Treatment (Procedure)
Crystallized Phenol
Participants receive combined treatment under local anesthesia. First, the pilonidal sinus area is cleaned and curetted, then crystallized phenol is applied into sinus channels. After a specified time, phenol is neutralized with normal saline, followed by laser treatment (SiLaC) application. Standard post-operative wound care is provided with same-day discharge.
干预措施: Crystallized Phenol (Drug)
结局指标
主要结局
Time to Complete Epithelialization
时间窗: From date of surgery until complete epithelialization is achieved, assessed up to 3 months
Time required for complete epithelialization of the pilonidal sinus wound, assessed by clinical examination during follow-up visits. Complete epithelialization is defined as full closure of the wound with healthy epithelial tissue covering the entire treated area.
次要结局
- Postoperative Pain Scores(Measured at 2 weeks, 4 weeks, and 3 months post-surgery)
- Return to Daily Activities Time(From date of surgery until return to normal activities, assessed up to 3 months)
- Complication Rate(From surgery through 3 months follow-up)
- Patient Satisfaction- VAS score Patient Satisfaction Patient Satisfaction(At 3 months post-surgery)