Phenol and Silver Nitrate Application in Pilonidal Sinus

Phase 4

Completed

• Conditions: Pilonidal Sinus of Natal Cleft; Pilonidal Sinus Without Abscess
• Interventions: Drug: Silver Nitrate; Drug: Phenol

• Registration Number: NCT04560049
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-06-03
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Primary Completion: 2022-06-15
• Study Completion: 2023-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver Nitrate Irrigation	Silver Nitrate	Surgical pit excision and silver nitrate irrigation of sinus tract
Phenolisation	Phenol	Surgical pit excision and phenolisation of sinus tract

Primary Outcome Measures

Name	Time	Method
Healing of the pilonidal sinus disease	8 week	Closure of pit without pus and soiling on physical examination

Secondary Outcome Measures

Name	Time	Method
Post-procedure Quality of life assessment	3rd and 8th week after the procedure	The quality of life of the patients will be determined by SF-36 test.
Wound infection	3rd and 8th week after the procedure	Wound infection is simply classifed as present or not present. It is considered as present when there was a an odd smelling purulent discharge from the wound.
Visual analog scale as pain assessment	3rd and 8th week after the procedure	Pain of the patients will be determined by VAS (visual analog scale). Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain

Trial Locations

Locations (1)

University of Health Sciences Umraniye Education and Research Hospital; 🇹🇷 İstanbul, Turkey