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Completed

NCT Number: NCT07567586

The Role of Platelet-rich Plasma Local Injection as 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University

Al Fayyum, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic pilonidal sinus .
  • Patients with recurrent pilonidal sinus.
  • Patients with large, painful pilonidal cyst.
  • Patients with multiple sinus tracks.

Exclusion criteria

  • 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.

Treatment and study plan

Group A :Platelet-rich plasma treatment

Drug

patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment

Group B: Control group

Drug

Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.

Primary outcomes

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

    Time frame: One month postoperative

Secondary outcomes

  1. Incidence of complications : like drainage state , wound infection & bleeding

    Time frame: one month postoperative

    Complications : like drainage state , wound infection & bleeding

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Assessment of the Role of Platelet-rich Plasma Local Injection as an Additional Treatment in Improvement of Pilonidal Sinus Surgery Outcomes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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