Pilonidal Sinus DiseaseNCT07567586
The Role of Platelet-rich Plasma Local Injection as Treatment in Improvement of Pilonidal Sinus Surgery Outcomes
A study testing Group A :Platelet-rich plasma treatment in people with Pilonidal Sinus Disease and Platelet-rich Plasma, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pilonidal Sinus Disease, Platelet-rich Plasma, Treatment
- What is being tested?
- Group A :Platelet-rich plasma treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 30 May 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic pilonidal sinus .
- Patients with recurrent pilonidal sinus.
- Patients with large, painful pilonidal cyst.
- Patients with multiple sinus tracks.
Who cannot join
- High risk for general anesthesia.
- Patients with high fever (39 C ).(active infection)
- Patients with bleeding rash around the wound .(inflammatory skin conditions)
- Patients with infected pilonidal sinus.
- Patients with autoimmune skin diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Role of Platelet-rich Plasma Local Injection as an Additional Treatment in Improvement of Pilonidal Sinus Surgery Outcomes
The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.
Read the detailed description
Pilonidal sinus disease is a chronic inflammatory condition of the skin and subcutaneous tissue that typically arises from hair follicles in the natal cleft of the sacrococcygeal region. The aetiology is debated but theorised to be a result of either the obstruction and subsequent inflammation of hair follicles, or acquired from hair penetrating through the skin into subcutaneous tissue.
It is a common problem affecting 26/100,000 of the general population, with an incidence of 1.1% in young adult males. It is a troublesome disease for patients, with negative impact on quality of life, mood, employment and self-image. It also results in a significant burden for the healthcare service, with high rates of recurrence and readmission following surgery. Definitive surgical management of Pilonidal sinus disease is challenging and remains a contentious issue. The aim of surgery is for the complete excision of affected tissue followed by prompt wound healing with a minimal recurrence rate. Numerous surgical procedures have been described for this purpose without a clear consensus on an optimal approach . Following excision, options for dealing with the resulting defect include healing by secondary intention, midline primary closure or lateral closure by a variety of flap techniques. The use of Platelet-rich plasma involves a complex network of molecular events which accelerate tissue regeneration due to its richness in growth factors plus a variety of biologic mediators. Platelet-rich plasma is an autologous product studied since the late 70s. It has been used in plastic and orthopedic surgery. It has a high concentration of platelets and growth factors (VEGF, PDGF, IGF-1, EGF). Platelets are activated and the suspension is applied to the desired location, stimulating vascular proliferation and promoting tissue healing. Platelet-rich plasma has more concentrated platelets than normal plasma (approximately 150-400×103 cell/dL). The presence of GFs in Platelet-rich plasma such as transforming growth factor-β, insulin-like growth factor1 co-stimulate the stem cells and fibroblasts secretions and promotes the fibrin matrix formation which effectively drive the healing process, induces regenerative response and lead to the damage structure repair in recovery of Pilonidal sinus disease disease. The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.
- Conditions
- Pilonidal Sinus Disease, Platelet-rich Plasma, Treatment
- Being tested
- Group A :Platelet-rich plasma treatment, Group B: Control group
- Keywords
- treatment, pilonidal sinus surgery, Platelet-rich plasma, local injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A :Platelet-rich plasma treatmentDrug
patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment
Group B: Control groupDrug
Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A( Platelet-rich plasma group) | Experimental | Group A : patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment. Receives: Drug: Group A :Platelet-rich plasma treatment |
| Group B (control group) | Placebo comparator | Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment. Receives: Drug: Group B: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of healing rate of the wound (dehiscence)
Measured: One month postoperative
Secondary outcomes (1)
Incidence of complications : like drainage state , wound infection & bleeding
Complications : like drainage state , wound infection \& bleeding
Measured: one month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start30 Mar 2023
- Primary completion30 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yassin Osman, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567586
- Sponsor's protocol ID
- SCCREIRB-MEDICINFAYOM-GU-001-0
- Status last verified
- Mar 2023
- First submitted
- 25 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of Platelet-rich Plasma Local Injection as an Additional Treatment in Improvement of Pilonidal Sinus Surgery Outcomes
- ClinicalTrials.gov ID
- NCT07567586
- Acronym / sponsor ID
- SCCREIRB-MEDICINFAYOM-GU-001-0
- Conditions
- Pilonidal Sinus Disease, Platelet-rich Plasma, Treatment
- Keywords
- treatment, pilonidal sinus surgery, Platelet-rich plasma, local injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 May 2026 (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 aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.
Detailed description
Pilonidal sinus disease is a chronic inflammatory condition of the skin and subcutaneous tissue that typically arises from hair follicles in the natal cleft of the sacrococcygeal region. The aetiology is debated but theorised to be a result of either the obstruction and subsequent inflammation of hair follicles, or acquired from hair penetrating through the skin into subcutaneous tissue.
It is a common problem affecting 26/100,000 of the general population, with an incidence of 1.1% in young adult males. It is a troublesome disease for patients, with negative impact on quality of life, mood, employment and self-image. It also results in a significant burden for the healthcare service, with high rates of recurrence and readmission following surgery. Definitive surgical management of Pilonidal sinus disease is challenging and remains a contentious issue. The aim of surgery is for the complete excision of affected tissue followed by prompt wound healing with a minimal recurrence rate. Numerous surgical procedures have been described for this purpose without a clear consensus on an optimal approach . Following excision, options for dealing with the resulting defect include healing by secondary intention, midline primary closure or lateral closure by a variety of flap techniques. The use of Platelet-rich plasma involves a complex network of molecular events which accelerate tissue regeneration due to its richness in growth factors plus a variety of biologic mediators. Platelet-rich plasma is an autologous product studied since the late 70s. It has been used in plastic and orthopedic surgery. It has a high concentration of platelets and growth factors (VEGF, PDGF, IGF-1, EGF). Platelets are activated and the suspension is applied to the desired location, stimulating vascular proliferation and promoting tissue healing. Platelet-rich plasma has more concentrated platelets than normal plasma (approximately 150-400×103 cell/dL). The presence of GFs in Platelet-rich plasma such as transforming growth factor-β, insulin-like growth factor1 co-stimulate the stem cells and fibroblasts secretions and promotes the fibrin matrix formation which effectively drive the healing process, induces regenerative response and lead to the damage structure repair in recovery of Pilonidal sinus disease disease. The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A( Platelet-rich plasma group) | Experimental | Drug: Group A :Platelet-rich plasma treatmentGroup A : patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment. |
| Group B (control group) | Placebo comparator | Drug: Group B: Control groupGroup B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic pilonidal sinus .
- Patients with recurrent pilonidal sinus.
- Patients with large, painful pilonidal cyst.
- Patients with multiple sinus tracks.
Key exclusion criteria (5 listed)
- High risk for general anesthesia.
- Patients with high fever (39 C ).(active infection)
- Patients with bleeding rash around the wound .(inflammatory skin conditions)
- Patients with infected pilonidal sinus.
- Patients with autoimmune skin 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 |
|---|---|---|
| Group A :Platelet-rich plasma treatmentpatients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment | Drug | Group A( Platelet-rich plasma group) |
| Group B: Control groupGroup B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment. | Drug | Group B (control group) |
Primary outcome
Incidence of healing rate of the wound (dehiscence)
Time frame: One month postoperative
1 secondary outcome
Incidence of complications : like drainage state , wound infection & bleeding
Time frame: one month postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A :Platelet-rich plasma treatment in people with Pilonidal Sinus Disease and Platelet-rich Plasma, run by Fayoum University at 1 site in Egypt.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 May 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of healing rate of the wound (dehiscence) (time frame: One month postoperative). 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 5 May 2026.