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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Fayoum University

    Al Fayyum

Other trials in Egypt

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.

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 groups in NCT07567586
Study groupRoleWhat they receive
Group A( Platelet-rich plasma group)ExperimentalGroup 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 comparatorGroup 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.

  1. Incidence of healing rate of the wound (dehiscence)

    Measured: One month postoperative

Secondary outcomes (1)
  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.

  1. First posted5 May 2026
  2. Study start30 Mar 2023
  3. Primary completion30 Mar 2025
  4. Study completion30 May 2025

Resources

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)
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

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.

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