RecruitingNot ApplicableNCT06324656

The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease

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


Sponsor

Necmi Kadıoğlu Hospital

Enrollment

100 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients.


Eligibility

Min Age: 1 DayMax Age: 18 Years

Inclusion Criteria1

  • The study will be included patients with pilonidal sinus disease aged between 0 to 18 years.

Exclusion Criteria1

  • 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.

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Interventions

PROCEDUREcrystallized phenol + platelet rich plasma application

At our pilonidal care clinic, patients will undergo a comprehensive treatment regimen starting with manual or laser hair removal to reduce hair by over 90%. For pilonidal abscesses, we will perform incision, drainage, and antibiotic therapy. Treatments will include local anesthesia with lidocaine and epinephrine, thorough disinfection with povidone-iodine, and wound irrigation. Sinuses will be treated by removing hair and curettage, followed by protective ointment application and crystallized phenol to fill the cavity, ensuring precise dosing and safety. For enhanced healing, crystallized phenol + platelet-rich plasma application patients will receive platelet-rich plasma injections to minimize infection risk and promote tissue regeneration, all under strict sterilization to maintain cleanliness and efficacy.

PROCEDUREcrystallized phenol

At our pilonidal care clinic, patients will undergo a comprehensive treatment regimen starting with manual or laser hair removal to reduce hair by over 90%. For pilonidal abscesses, we will perform incision, drainage, and antibiotic therapy. Treatments will include local anesthesia with lidocaine and epinephrine, thorough disinfection with povidone-iodine, and wound irrigation. Sinuses will be treated by removing hair and curettage, followed by protective ointment application and crystallized phenol to fill the cavity, ensuring precise dosing and safety.


Locations(1)

Mustafa Azizoğlu

Istanbul, Turkey (Türkiye)

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NCT06324656


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