Phenol and Silver Nitrate Application in Pilonidal Sinus

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

Sponsors

Lead Sponsor: Umraniye Education and Research Hospital

Source 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.

Overall Status Recruiting
Start Date 2020-06-03
Completion Date 2022-06-15
Primary Completion Date 2021-06-15
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Healing of the pilonidal sinus disease 8 week
Secondary Outcome
Measure Time Frame
Quality of life 3rd and 8th week after the prosedure
Wound infection 3rd and 8th week after the prosedure
Pain 3rd and 8th week after the prosedure
Enrollment 140
Condition
Intervention

Intervention Type: Drug

Intervention Name: Silver Nitrate

Description: application of silver nitrate to sinus tract

Arm Group Label: Silver Nitrate Irrigation

Intervention Type: Drug

Intervention Name: Phenol

Description: phenolisation of sinus tract

Arm Group Label: Phenolisation

Eligibility

Criteria:

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. 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hanife Ş Ülgür Principal Investigator University of Health Sciences Umraniye Education and Research Hospital
Overall Contact

Last Name: Hanife Ş Ülgür

Phone: +905058302130

Email: [email protected]

Location
Facility: Status: Contact: University of Health Sciences Umraniye Education and Research Hospital Hanife Ş Ülgür 05058302130 [email protected]
Location Countries

Turkey

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Umraniye Education and Research Hospital

Investigator Full Name: Hanife Seyda Ulgur

Investigator Title: Assistant Doctor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Phenolisation

Type: Experimental

Description: Surgical pit excision and phenolisation of sinus tract

Label: Silver Nitrate Irrigation

Type: Active Comparator

Description: Surgical pit excision and silver nitrate irrigation of sinus tract

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News