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临床试验/NCT04560049
NCT04560049已完成4 期

Comparison of Phenol and Silver Nitrate Application in the Sacrococcygeal Pilonidal Sinus: A Prospective Randomized Controlled Study

Umraniye Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年6月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Healing of the pilonidal sinus disease

研究概览

简要总结

Pilonidal sinus is a disease that affects the young population. Wound healing is a problem after surgical interventions Especially wound healing brings minimally invasive interventions to the fore. In this study we will administer two types of irritating agent for pilonidal sinus disesase. One of them is phenol and second one is silver nitrate solution. And not routinely used for pilonidal sinus disease. The data about availeble in pubmed and google scholar is limited focused on silver nitrate The goal of the study is to compare the silver nitrate and phenol application

详细描述

Sacrococcygeal pilonidal sinus disease is a chronic subcutaneous tissue inflammation that most commonly affects the male sex between the ages of 20 and 30, characterized by burning, itching and discharge in the internal gluteal cleft. It affects the young working population, short return to work after treatment and early return to daily normal activity is socioeconomically important. Although approximately 15 different surgical techniques have been described in the literature in the treatment of pilonidal sinus, a gold standard approach has not been determined. Since it is seen in the young working population, it is important that the ideal treatment has an easy-to-apply, low cost and fast recovery process. The effectiveness of phenol administration as a minimally invasive procedure has been demonstrated with acceptable complication and success rates in prospective and retrospective studies.

Silver nitrate is a caustic and sclerosing substance that impairs tract integrity, such as phenol. It supports the closure of the sinus tract by cauterizing the granulation and epithelialized tissue throughout the sinus. It also has antimicrobial properties to reduce microbial load throughout the tract. Although the effective use and successful results of silver nitrate in the treatment of perianal fistula have been shown, a prospective study has not been conducted yet on the use of pilonidal sinus.

The main purpose of the study is to compare return to normal daily activity between the two groups. This period will be measured in days from the intervention. Participants will not be offered any restrictions after the intervention, and the period of returning to normal daily activities such as starting work at work or doing the housework will be determined by filling out a two-week daily questionnaire. Secondary goals; quality of life, complaints related to pilonidal sinus (itching, burning, discharge), wound infection, closure of pilonidal sinus mouth, recurrence rate and VAS (visual analog scale) scoring.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Patients who applied to general surgery outpatient clinic for chronic sacrococcygeal pilonidal sinus
  • Patients with written informed voluntary consent forms.

排除标准

  • BMI > 35 kg/m²
  • Recurrent cases
  • Active abscess formation
  • Patients with hydradenitis suppurativa and skin lesions in the perianal region
  • Patients with accompanying anal fistula, anal conduloma and perianal involvement of Crohn's disease
  • Immunosuppressive patients (HIV +, organ transplantation, patients receiving immunosuppressive therapy)
  • Complicated cases (have more than 3 orifice)
  • Patients with known allergic sensitivity to one of the silver nitrate, phenol, nitrofurazone and prilocaine substances

研究组 & 干预措施

Phenolisation

Experimental

Surgical pit excision and phenolisation of sinus tract

干预措施: Phenol (Drug)

Silver Nitrate Irrigation

Active Comparator

Surgical pit excision and silver nitrate irrigation of sinus tract

干预措施: Silver Nitrate (Drug)

结局指标

主要结局

Healing of the pilonidal sinus disease

时间窗: 8 week

Closure of pit without pus and soiling on physical examination

次要结局

  • Post-procedure Quality of life assessment(3rd and 8th week after the procedure)
  • Wound infection(3rd and 8th week after the procedure)
  • Visual analog scale as pain assessment(3rd and 8th week after the procedure)

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hanife Seyda Ulgur

Assistant Doctor

Umraniye Education and Research Hospital

研究点 (1)

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