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Chemical Agent
Phenol and Silver Nitrate Application in Pilonidal Sinus
Phase 4
Waitlist Available
Led By Hanife Ş Ülgür
Research Sponsored by Umraniye Education and Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3rd and 8th week after the procedure
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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
Eligible Conditions
- Pilonidal cyst
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3rd and 8th week after the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3rd and 8th week after the procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Healing of the pilonidal sinus disease
Secondary study objectives
Post-procedure Quality of life assessment
Visual analog scale as pain assessment
Wound infection
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PhenolisationExperimental Treatment1 Intervention
Surgical pit excision and phenolisation of sinus tract
Group II: Silver Nitrate IrrigationActive Control1 Intervention
Surgical pit excision and silver nitrate irrigation of sinus tract
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenol
FDA approved
Find a Location
Who is running the clinical trial?
Umraniye Education and Research HospitalLead Sponsor
62 Previous Clinical Trials
23,534 Total Patients Enrolled
Hanife Ş ÜlgürPrincipal InvestigatorUniversity of Health Sciences Umraniye Education and Research Hospital