Pilonidal SinusNCT06324656
The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease
A study testing crystallized phenol + platelet rich plasma application and crystallized phenol in people with Pilonidal Sinus, run by Necmi Kadıoğlu Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- crystallized phenol + platelet rich plasma application and crystallized phenol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study will be included patients with pilonidal sinus disease aged between 0 to 18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mustafa Azizoğlu
Istanbul, 34430
Mustafa Azizoğlu, +905447448244, mdmazizoglu@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pilonidal Sinus
- Being tested
- crystallized phenol + platelet rich plasma application, crystallized phenol
- Keywords
- pilonidal sinus, Children, platelet rich plasma
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crystallized phenol + platelet rich plasma applicationProcedure or 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 phenolProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Crystallized phenol | Active comparator | Crystallized phenol group: The patients will undergo to crystallized phenol application. Receives: 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. Receives: Procedure: crystallized phenol + platelet rich plasma application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time to full daily activities
It refers to the time when patients return to their routine lives after the procedure.
Measured: 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.
Measured: 2 weeks
Healing time
It refers to the wound healing time of the patients after the procedure.
Measured: 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.
Measured: 7 weeks
Success rate
The succes rate will be calculated after interventions
Measured: 7 weeks
Recurrence rate
The recurrence rate will be calculated after interventions
Measured: 7 weeks
Secondary outcomes (4)
Bleeding rate
Bleeding during interventions will be calculated
Measured: 1 week
Infection rate
Infection will be defined during interventions and 10 days after intervention
Measured: 7 weeks
Skin burn rate
Skin burn during interventions will be calculated
Measured: 7 weeks
Total complication rate
Total complicaitons during interventions will be calculated
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start21 Nov 2023
- Primary completion29 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmi Kadıoğlu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324656
- Sponsor's protocol ID
- PRP-PNS
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39307596
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06324656
- Acronym / sponsor ID
- PRP-PNS
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal sinus, Children, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Necmi Kadıoğlu HospitalUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystallized phenol | Active comparator | Procedure: crystallized phenolCrystallized phenol group: The patients will undergo to crystallized phenol application. |
| Crystallized phenol + platelet rich plasma | Experimental | Procedure: crystallized phenol + platelet rich plasma applicationCrystallized phenol + platelet rich plasma group. Alongside the crystallized phenol application + patients also will receive platelet rich plasma injections in the same session. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study will be included patients with pilonidal sinus disease aged between 0 to 18 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crystallized phenol + platelet rich plasma applicationAt 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. | Procedure or surgery | Crystallized phenol + platelet rich plasma |
| crystallized phenolAt 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. | Procedure or surgery | Crystallized phenol |
Primary outcome
Average time to full daily activities
Time frame: 1 week
It refers to the time when patients return to their routine lives after the procedure.
VAS scores
Time frame: 2 weeks
Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days following the procedure.
Healing time
Time frame: 7 weeks
It refers to the wound healing time of the patients after the procedure.
Cosmetic score
Time frame: 7 weeks
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.
Success rate
Time frame: 7 weeks
The succes rate will be calculated after interventions
Recurrence rate
Time frame: 7 weeks
The recurrence rate will be calculated after interventions
4 secondary outcomes
Bleeding rate
Time frame: 1 week
Infection rate
Time frame: 7 weeks
Skin burn rate
Time frame: 7 weeks
Total complication rate
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39307596Azizoglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crystallized phenol + platelet rich plasma application and crystallized phenol in people with Pilonidal Sinus, run by Necmi Kadıoğlu Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Azizoğlu, MD, PhD (+905447448244, mdmazizoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average time to full daily activities (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.