Combining Platelet-rich Plasma and Crystallized Phenol to Treat Pilonidal Sinus Disease in Children A Randomized Controlled Trial
Led by Necmi Kadıoğlu Hospital · Updated on 2024-08-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining platelet-rich plasma PRP with crystallized phenol treatment for pilonidal sinus disease in children. Pilonidal sinus disease involves infections near the tailbone, and previous treatments have used phenol due to its antiseptic and anesthetic properties. This study aims to see if adding PRP after crystallized phenol can speed healing and improve outcomes in pediatric patients.
Patients begin treatment with manual or laser hair removal to reduce hair in the affected area by over 90%. Those with abscesses receive incision, drainage, and antibiotics first. Under local anesthesia, the sinus area is cleaned and disinfected, hair and granulation tissue removed, and crystallized phenol is applied carefully to fill the cavity. In one group, PRP injections are also given around the wound during the same session to promote tissue healing.
During the study, participants are monitored for healing progress, pain levels, cosmetic results, and recurrence of the sinus over several weeks. Researchers will assess the time to return to daily activities, healing time, and rates of complications such as bleeding, infection, and skin burns. Follow-up visits and evaluations continue for seven weeks to track treatment success and safety.
CONDITIONS
Brief Title
The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease
Research Team
M
Mustafa Azizoğlu, MD, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Unable to attend post-procedural outpatient follow-ups
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session with follow-up up to 7 weeks
Participants receive treatment for pilonidal sinus disease including hair removal through manual shaving or laser epilation, local anesthesia, disinfection, wound irrigation, hair removal and curettage of the sinus, ointment application, and crystallized phenol application. Participants in the experimental group will also receive a platelet-rich plasma injection during the same session.
1 treatment visit and multiple outpatient follow-up visits over 7 weeks
Follow-up
Duration - Up to 7 weeks
Participants attend outpatient follow-up visits to monitor healing, assess pain levels, cosmetic outcomes, and any complications such as bleeding, infection, or skin burns.
Multiple outpatient visits over 7 weeks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Study of Bascom Cleft Lift Surgery for Healing Complex or Recurrent Pilonidal Sinus Disease
Comparing Three Minimally Invasive Treatments for Pilonidal Sinus Disease Pit Picking, Phenol Application, and Their Combination
Comparing Negative Pressure Wound Therapy to Standard Open Wound Care After Pilonidal Sinus Surgery in Adults
Registry Study Evaluating Safety and Outcomes of Myriad Matrix and Morcells Devices in Soft Tissue Reconstruction Surgery
Comparing Karydakis Flap, Primary Closure, and Bascoms Pit-Pick Surgery for Treating Pilonidal Sinus in Women
Comparing Four Surgical Treatments for Sacrococcygeal Pilonidal Sinus in Adolescents
Observational Study on Recurrence Rates After Laser Treatment for Pilonidal Sinus in Adults
Ultrasound-Guided Sacral Erector Spinae Plane Block for Pain Relief After Pilonidal Sinus Surgery in Adults Up to 65 Years
Combining Platelet-rich Plasma and Crystallized Phenol to Treat Pilonidal Sinus Disease in Children A Randomized Controlled Trial
Testing Twice-Daily 1% Clascoterone Cream for Pilonidal Disease Treatment Over 12 Weeks
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Platelet-rich Plasma as an Adjuvant Therapy to Crystallized Phenol in the Treatment of Pediatric Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial.
Mustafa Azizoglu, Sergey Klyuev, Tahsin Onat Kamci...