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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorNecmi Kadıoğlu Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • crystallized phenol + platelet rich plasma application

    Procedure/Surgery

    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.

  • crystallized phenol

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Crystallized phenolActive comparator 1 intervention
Group B: Crystallized phenol + platelet rich plasmaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average time to full daily activities

It refers to the time when patients return to their routine lives after the procedure.

Time frame
1 week
2

VAS scores

Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days following the procedure.

Time frame
2 weeks
3

Healing time

It refers to the wound healing time of the patients after the procedure.

Time frame
7 weeks
4

Cosmetic score

All patients will be assessed for cosmetic score after healing. For cosmetic evaluation, observers were asked to assess the scar in comparison to normal skin by answering the question, "What is your overall opinion of the scar compared to normal skin?" They rated the scar on a scale from 1 to 10, where 10 signifies normal skin and 1 represents a very different, worst possible scar.

Time frame
7 weeks

Secondary outcomes

1

Bleeding rate

Bleeding during interventions will be calculated

Time frame
1 week
2

Infection rate

Infection will be defined during interventions and 10 days after intervention

Time frame
7 weeks
3

Skin burn rate

Skin burn during interventions will be calculated

Time frame
7 weeks
4

Total complication rate

Total complicaitons during interventions will be calculated

Time frame
7 weeks

Other outcomes

Sponsors and contacts

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