Combining platelet-rich plasma with crystallized phenol for treating pilonidal sinus in children
The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease Treatment in Children: A Double-blind Single-center Randomized Controlled Trial
This study is testing if combining platelet-rich plasma with crystallized phenol can help children with pilonidal sinus heal better than just using crystallized phenol alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Necmi Kadıoğlu Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06324656 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using platelet-rich plasma (PRP) in conjunction with crystallized phenol to treat pilonidal sinus disease in pediatric patients. Patients will undergo a regimen that includes manual shaving, laser epilation, and, if necessary, incision and drainage for abscesses. The treatment aims to accelerate healing and improve outcomes compared to traditional methods that rely solely on crystallized phenol. The study will evaluate the efficacy of this combined approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years diagnosed with pilonidal sinus disease.
Not a fit: Patients who have previously undergone surgery for pilonidal sinus disease or have anomalies in the sacrococcygeal region may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to faster healing and improved outcomes for children suffering from pilonidal sinus disease.
How similar studies have performed: While the use of crystallized phenol has been documented, the combination with platelet-rich plasma is a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The study will be included patients with pilonidal sinus disease aged between 0 to 18 years. Exclusion Criteria: Patients who had undergone prior pilonidal sinus disease surgery or had anomalies in the sacrococcygeal region will be excluded from the study. Additionally, patients who will decline to participate in the study or will be failed to attend post-procedural outpatient follow-ups will also be excluded.
Where this trial is running
Istanbul
- Mustafa Azizoğlu — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa Azizoğlu, MD, PhD
- Email: mdmazizoglu@gmail.com
- Phone: +905447448244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.