Pilonidal SinusNCT06391307
The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children
A study testing Crystallized phenol, Crystallized phenol + Exosome and Crystallized phenol + Stem Cell in people with Pilonidal Sinus and Pilonidal Disease, run by Mustafa Azizoğlu at 1 site in Turkey (Türkiye).
Trial summary
Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Pilonidal Sinus, Pilonidal Disease
- What is being tested?
- Crystallized phenol, Crystallized phenol + Exosome and Crystallized phenol + Stem Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2024to 30 Dec 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
- 0-18 years children.
- Patients with chronic non-healing wound and pilonidal sinus diseases.
Who cannot join
- Patients with epilepsia
- Patients with diabetes
- Patients with hypertension
- Patients with chronic other diseases.
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 Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial
Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Substantial evidence suggests that mesenchymal stem cells (MSCs) can facilitate the healing of chronic wounds in both animal models and preclinical studies, primarily through their paracrine actions. The bioactive factors and cytokines secreted by MSCs can be harvested in the form of conditioned medium. This medium has been processed into a lyophilized powder for clinical use. Patients with chronic wounds will recruited and divided into two groups: the control group will receive the commonly used fibroblast growth factor, while the experimental group was treated with the lyophilized powder. The study aims to assess the efficacy and safety of this Stem cell and exosome in treating chronic wounds (especially pilonidal sinus).
Read the detailed description
Pilonidal sinus disease (PSD) is an infectious or inflammatory condition beneath the skin at the peak of the gluteal cleft in the sacrococcygeal area. It is a chronic condition characterized by discharge, infection, and pain. Although it can occur during adolescence, it is most commonly seen in adult males, leading to a focus on adult treatments in research. Surgical treatment was first implemented by Anderson in 1847. Since then, various surgical and medical treatment options have been explored, yet there is no widely accepted standardized treatment. The ideal treatment should be simple, require a short hospital stay, have low recurrence rates, provide good cosmetic results, be cost-effective, cause minimal pain, and allow a quick return to social life, making the surgical approach contentious.
Maurice and Greenwood first reported the application of liquid phenol in 1964, initially under general anesthesia, later shifting to local anesthesia. Due to high recurrence rates with liquid phenol, Dogru and colleagues introduced the crystallized phenol (CP) procedure, a minimally invasive method now commonly used in adults.
Recent years have shown that stem cells and exosomes promote tissue healing and reduce inflammation. Known for their ability to differentiate into various cell types, stem cells, and exosomes play critical roles in intercellular communication, containing a variety of molecules. Their use in surgical fields has become popular as they speed up the post-operative healing process and reduce the risk of complications. Research in the literature supports that stem cells and exosomes accelerate wound healing (e.g., Nourian Dehkordi A, et al. 2019).
This study is based on two main premises: firstly, to identify the potential healing effects of stem cell and exosome applications in treating pilonidal sinus disease; and secondly, to comparatively assess the impact of these applications on surgical outcomes, specifically regarding surgery duration, complications, and the healing process. Comparing these two groups will help determine the value of stem cell and exosome applications in managing pilonidal sinus disease.
- Conditions
- Pilonidal Sinus, Pilonidal Disease
- Being tested
- Crystallized phenol, Crystallized phenol + Exosome, Crystallized phenol + Stem Cell, Crystallized phenol + Exosome + Stem Cell
- Keywords
- pilonidal sinus disease, Children, wound healing, stem cell, exosome
- 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 phenolOther
Also called Crystallized phenol will be applied to wound area.
Crystallized phenol + Exosome + Stem Cell
Crystallized phenol + ExosomeBiological
Crystallized phenol + Exosome will be applied to wound area.
Crystallized phenol + Stem CellBiological
Crystallized phenol + Stem cell will be applied to wound area.
Crystallized phenol + Exosome + Stem CellBiological
Crystallized phenol + Exosome + Stem Cell will be applied to wound area.
| Study group | Role | What they receive |
|---|---|---|
| Crystallized phenol | Active comparator | In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol into the wound. Receives: Other: Crystallized phenol |
| Crystallized phenol + Exosome | Experimental | In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Exosome into the wound. Receives: Biological: Crystallized phenol + Exosome |
| Crystallized phenol + Stem Cell | Experimental | In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell into the wound. Receives: Biological: Crystallized phenol + Stem Cell |
| Crystallized phenol + Exosome + Stem Cell | Experimental | In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell + Exosome into the wound. Receives: Biological: Crystallized phenol + Exosome + Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
In the control group, the healing process generally takes about 2-3 weeks. In the experimental group, a shorter duration is expected. In this study, the wound healing times of both groups will be evaluated and compared.
Measured: 3 weeks
Cosmetic results
In this study, the worst healing wounds will receive a score of 1, and the best-healed wounds, which are closest to normal skin, will receive a score of 10. In short, a low score indicates poor wound healing and poor cosmetic, while a high score indicates that the wound has achieved a good cosmetic appearance.
Measured: 2 month
Skin burn rate
In patients treated with crystallized phenol, skin burns can occur during application. To prevent this, Furacin ointment is applied around the wound. However, we still encounter skin burns. In this study, it is expected that the experimental groups will have a lower burn rate compared to the control group. The burn rate will be evaluated in this study.
Measured: 2 weeks
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 score
Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days, 20 days following the procedure and after recovery.
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 (3)
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 week
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 posted30 Apr 2024
- Study start11 May 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Azizoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Necmi Kadıoğlu Hospital
- Responsible party
- Sponsor-investigator, Mustafa Azizoğlu, Necmi Kadıoğlu Hospital
- Investigators
- Mustafa Azizoğlu, MD, Principal investigator, Esenyurt State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391307
- Sponsor's protocol ID
- Stem Cell PNS
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06391307
- Acronym / sponsor ID
- Stem Cell PNS
- Conditions
- Pilonidal Sinus, Pilonidal Disease
- Keywords
- pilonidal sinus disease, Children, wound healing, stem cell, exosome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mustafa AzizoğluUniversity, hospital or other
- Collaborators
- Necmi Kadıoğlu Hospital
- Study start
- 11 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Apr 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.
Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Substantial evidence suggests that mesenchymal stem cells (MSCs) can facilitate the healing of chronic wounds in both animal models and preclinical studies, primarily through their paracrine actions. The bioactive factors and cytokines secreted by MSCs can be harvested in the form of conditioned medium. This medium has been processed into a lyophilized powder for clinical use. Patients with chronic wounds will recruited and divided into two groups: the control group will receive the commonly used fibroblast growth factor, while the experimental group was treated with the lyophilized powder. The study aims to assess the efficacy and safety of this Stem cell and exosome in treating chronic wounds (especially pilonidal sinus).
Detailed description
Pilonidal sinus disease (PSD) is an infectious or inflammatory condition beneath the skin at the peak of the gluteal cleft in the sacrococcygeal area. It is a chronic condition characterized by discharge, infection, and pain. Although it can occur during adolescence, it is most commonly seen in adult males, leading to a focus on adult treatments in research. Surgical treatment was first implemented by Anderson in 1847. Since then, various surgical and medical treatment options have been explored, yet there is no widely accepted standardized treatment. The ideal treatment should be simple, require a short hospital stay, have low recurrence rates, provide good cosmetic results, be cost-effective, cause minimal pain, and allow a quick return to social life, making the surgical approach contentious.
Maurice and Greenwood first reported the application of liquid phenol in 1964, initially under general anesthesia, later shifting to local anesthesia. Due to high recurrence rates with liquid phenol, Dogru and colleagues introduced the crystallized phenol (CP) procedure, a minimally invasive method now commonly used in adults.
Recent years have shown that stem cells and exosomes promote tissue healing and reduce inflammation. Known for their ability to differentiate into various cell types, stem cells, and exosomes play critical roles in intercellular communication, containing a variety of molecules. Their use in surgical fields has become popular as they speed up the post-operative healing process and reduce the risk of complications. Research in the literature supports that stem cells and exosomes accelerate wound healing (e.g., Nourian Dehkordi A, et al. 2019).
This study is based on two main premises: firstly, to identify the potential healing effects of stem cell and exosome applications in treating pilonidal sinus disease; and secondly, to comparatively assess the impact of these applications on surgical outcomes, specifically regarding surgery duration, complications, and the healing process. Comparing these two groups will help determine the value of stem cell and exosome applications in managing pilonidal sinus disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crystallized phenol | Active comparator | Other: Crystallized phenolIn this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol into the wound. |
| Crystallized phenol + Exosome | Experimental | Biological: Crystallized phenol + ExosomeIn this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Exosome into the wound. |
| Crystallized phenol + Stem Cell | Experimental | Biological: Crystallized phenol + Stem CellIn this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell into the wound. |
| Crystallized phenol + Exosome + Stem Cell | Experimental | Biological: Crystallized phenol + Exosome + Stem CellIn this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell + Exosome into the wound. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 0-18 years children.
- Patients with chronic non-healing wound and pilonidal sinus diseases.
Key exclusion criteria (4 listed)
- Patients with epilepsia
- Patients with diabetes
- Patients with hypertension
- Patients with chronic other diseases.
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 phenolAlso: Crystallized phenol will be applied to wound area.Crystallized phenol + Exosome + Stem Cell | Other | Crystallized phenol |
| Crystallized phenol + ExosomeCrystallized phenol + Exosome will be applied to wound area. | Biological | Crystallized phenol + Exosome |
| Crystallized phenol + Stem CellCrystallized phenol + Stem cell will be applied to wound area. | Biological | Crystallized phenol + Stem Cell |
| Crystallized phenol + Exosome + Stem CellCrystallized phenol + Exosome + Stem Cell will be applied to wound area. | Biological | Crystallized phenol + Exosome + Stem Cell |
Primary outcome
Wound healing time
Time frame: 3 weeks
In the control group, the healing process generally takes about 2-3 weeks. In the experimental group, a shorter duration is expected. In this study, the wound healing times of both groups will be evaluated and compared.
Cosmetic results
Time frame: 2 month
In this study, the worst healing wounds will receive a score of 1, and the best-healed wounds, which are closest to normal skin, will receive a score of 10. In short, a low score indicates poor wound healing and poor cosmetic, while a high score indicates that the wound has achieved a good cosmetic appearance.
Skin burn rate
Time frame: 2 weeks
In patients treated with crystallized phenol, skin burns can occur during application. To prevent this, Furacin ointment is applied around the wound. However, we still encounter skin burns. In this study, it is expected that the experimental groups will have a lower burn rate compared to the control group. The burn rate will be evaluated in this study.
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 score
Time frame: 7 weeks
Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days, 20 days following the procedure and after recovery.
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
3 secondary outcomes
Bleeding rate
Time frame: 1 week
Infection rate
Time frame: 7 week
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 14 May 2024.
- 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.
Mustafa Azizoğlu, MD principal investigator
Esenyurt State Hospital
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, Crystallized phenol + Exosome and Crystallized phenol + Stem Cell in people with Pilonidal Sinus and Pilonidal Disease, run by Mustafa Azizoğlu 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 2 inclusion and 4 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 14 May 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?
Wound healing time (time frame: 3 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.