Actively Recruiting
Led by Necmi Kadıoğlu Hospital · Updated on 2024-08-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
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
The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Mustafa Azizoğlu
Istanbul, Turkey (Türkiye), 34430
Actively Recruiting
M
Mustafa Azizoğlu, MD, PhD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mustafa Azizoglu, Sergey Klyuev, Tahsin Onat Kamci...
https://pubmed.ncbi.nlm.nih.gov/39307596