A Phase 4 interventional study of Silver Nitrate and Phenol in Pilonidal Sinus of Natal Cleft and Pilonidal Sinus Without Abscess, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Umraniye Education and Research Hospital · Phase 4, Interventional, and Treatment
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
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.
Exclusion Criteria:
Surgical pit excision and phenolisation of sinus tract
Drug: Phenol
Surgical pit excision and silver nitrate irrigation of sinus tract
Drug: Silver Nitrate
application of silver nitrate to sinus tract
phenolisation of sinus tract
Healing of the pilonidal sinus disease
Closure of pit without pus and soiling on physical examination
Time frame: 8 week
Post-procedure Quality of life assessment
The quality of life of the patients will be determined by SF-36 test.
Time frame: 3rd and 8th week after the procedure
Wound infection
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.
Time frame: 3rd and 8th week after the procedure
Visual analog scale as pain assessment
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
Time frame: 3rd and 8th week after the procedure
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Umraniye Education and Research Hospital