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The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children

The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06391307
Enrollment
120
Registered
2024-04-30
Start date
2024-05-11
Completion date
2024-12-30
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Disease, Pilonidal Sinus

Keywords

pilonidal sinus disease, Children, wound healing, stem cell, exosome

Brief 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. 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.

Interventions

Crystallized phenol + Exosome + Stem Cell

BIOLOGICALCrystallized phenol + Exosome

Crystallized phenol + Exosome will be applied to wound area.

BIOLOGICALCrystallized phenol + Stem Cell

Crystallized phenol + Stem cell will be applied to wound area.

BIOLOGICALCrystallized phenol + Exosome + Stem Cell

Crystallized phenol + Exosome + Stem Cell will be applied to wound area.

Sponsors

Necmi Kadıoğlu Hospital
CollaboratorOTHER
Mustafa Azizoğlu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* 0-18 years children. * Patients with chronic non-healing wound and pilonidal sinus diseases.

Exclusion criteria

* Patients with epilepsia * Patients with diabetes * Patients with hypertension * Patients with chronic other diseases.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate7 weeksThe recurrence rate will be calculated after interventions
Average time to full daily activities1 weekIt refers to the time when patients return to their routine lives after the procedure.
VAS score7 weeksPatient 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 rate7 weeksThe succes rate will be calculated after interventions
Wound healing time3 weeksIn 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 results2 monthIn 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 rate2 weeksIn 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.

Secondary

MeasureTime frameDescription
Infection rate7 weekInfection will be defined during interventions and 10 days after intervention
Total complication rate7 weeksTotal complicaitons during interventions will be calculated
Bleeding rate1 weekBleeding during interventions will be calculated

Countries

Turkey (Türkiye)

Contacts

Primary ContactMustafa Azizoğlu, MD, PhD
mdmazizoglu@gmail.com+905447448244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026