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

NCT06324656 | Recruiting

• 1 other identifier: PRP-PNS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pilonidal Sinus

Keywords

pilonidal sinus; Children; platelet rich plasma

Outcome Measures

Primary Outcomes (6)

• Average time to full daily activities

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

  1 week

• VAS scores

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

  2 weeks

• Healing time

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

  7 weeks

• 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.

  7 weeks

• Success rate

  The succes rate will be calculated after interventions

  7 weeks

• Recurrence rate

  The recurrence rate will be calculated after interventions

  7 weeks

Secondary Outcomes (4)

• Bleeding rate

  1 week

• Infection rate

  7 weeks

• Skin burn rate

  7 weeks

• Total complication rate

  7 weeks

Study Arms (2)

Crystallized phenol

ACTIVE COMPARATOR

Crystallized phenol group: The patients will undergo to crystallized phenol application.

Procedure: crystallized phenol

Crystallized phenol + platelet rich plasma

EXPERIMENTAL

Crystallized phenol + platelet rich plasma group. Alongside the crystallized phenol application + patients also will receive platelet rich plasma injections in the same session.

Procedure: crystallized phenol + platelet rich plasma application

Interventions

crystallized phenol + platelet rich plasma application PROCEDURE

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 + platelet rich plasma

crystallized phenol PROCEDURE

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.

Crystallized phenol

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmi Kadıoğlu Hospital: lead

Study Sites (1)

Mustafa Azizoğlu

Istanbul, 34430, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Azizoglu M, Klyuev S, Kamci TO, Okur MH. Platelet-rich Plasma as an Adjuvant Therapy to Crystallized Phenol in the Treatment of Pediatric Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial. J Pediatr Surg. 2025 Jan;60(1):161934. doi: 10.1016/j.jpedsurg.2024.161934. Epub 2024 Sep 14.

  PMID: 39307596 DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Mustafa Azizoğlu, MD, PhD

CONTACT

+905447448244; mdmazizoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 22, 2024
• Study Start: November 21, 2023
• Primary Completion: September 29, 2024
• Study Completion: September 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)