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

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: crystallized phenol; Procedure: crystallized phenol + platelet rich plasma application

Detailed Description

Upon their arrival at our pilonidal care clinic, patients commenced a regimen of manual shaving of the gluteal cleft either weekly or bi-weekly. Laser epilation therapy was initiated at the earliest opportunity, conducted every 6 to 8 weeks, aiming for a hair reduction of over 90%. For patients presenting with a pilonidal abscess, an initial procedure of incision and drainage was performed, followed by antibiotic therapy. In the outpatient clinic, patients were placed in a prone position, and the area was sterilized with a povidone-iodine solution.

Anaesthesia local: The skin and subcutaneous tissues surrounding the PSD area, including the sinus openings, receive local anesthesia with 5 ml of lidocaine (20 mg/ml) mixed with epinephrine (0.0125 mg/ml).

Zone keeps clean: The area surrounding the PSD is thoroughly disinfected with povidone-iodine solution, covering a minimum area of 20 square centimeters to ensure adequate local disinfection.

Irrigation with isotonic solution: The wound is washed with sterile isotonic solution.

Zero hair (removing hair and curettage): For sinuses measuring ≤ 3 mm in diameter, dilation is performed using a mosquito clamp (BH-109, Aesculap®, Center Valley, PA, USA). Hair within the sinus is removed. After the complete removal of hair from the area, the granulation tissue is then excised through curettage.

Ointment application around the wound: To prevent skin necrosis and burns, a 0.2% nitrofurazone (Furacin® Eczacıbası İlaç San, Istanbul, Turkey) ointment is meticulously applied around the pilonidal sinus area immediately before the CP application, ensuring a protective barrier and enhancing skin safety.

Gravel-like crystallized phenol application: In this instance, the phenol applied is not in liquid form; rather, it is in a solid, gravel-like form. CP (BotaFarma İlaç Medikal İtriyat Kimya San. Tic. Ltd. Şti, Ankara, Turkey) is carefully administered into the cavity via the orifice, with the precise amount required just sufficient to fill the cavity without causing any overflow. This step necessitates meticulous attention to ensure the correct dosage and prevent any potential spillage. Typically, for an average pediatric patient and the size of the defect encountered, an amount ranging from 4 to 6 grams of phenol is deemed adequate to effectively treat the area while minimizing risk.

Local re-disinfection prior to PRP injection: Up to this point, all procedures are identical for both groups. However, the following steps and any subsequent applications are exclusively for Group 2. The area around the pilonidal sinus should be thoroughly disinfected again with povidone-iodine (care should be taken to prevent povidone-iodine from entering the sinus itself). This step is critical because, following this phase, a PRP injection will be administered into the tissue, necessitating that the skin is properly disinfected to minimize the risk of infection.

Undergo PRP injection: In Group 2, patients received a PRP injection during the same session as the CP application. The amount of PRP injected-approximately 1-2 ml, depending on the size of the pilonidal sinus-was administered around the edges and surrounding area of the wound.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Azizoğlu, MD, PhD; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34430
    • Recruiting
    • Mustafa Azizoğlu
    • Contact: Mustafa Azizoğlu; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Crystallized phenol; Crystallized phenol group: The patients will undergo to crystallized phenol application.	Procedure: crystallized 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.
Experimental: Crystallized phenol + platelet rich plasma; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding rate	Bleeding during interventions will be calculated	1 week
Infection rate	Infection will be defined during interventions and 10 days after intervention	7 weeks
Skin burn rate	Skin burn during interventions will be calculated	7 weeks
Total complication rate	Total complicaitons during interventions will be calculated	7 weeks

Collaborators and Investigators

• Sponsor: Necmi Kadıoğlu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; platelet rich plasma; pilonidal sinus
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Cysts; Otorhinolaryngologic Diseases; Nose Diseases; Pilonidal Sinus; Paranasal Sinus Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Phenol
• Other Study ID Numbers: PRP-PNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No