The Role of Platelet-rich Plasma Local Injection as Treatment in Improvement of Pilonidal Sinus Surgery Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Treatment; Platelet-rich Plasma; Pilonidal Sinus Disease
• Intervention / Treatment: Drug: Group A :Platelet-rich plasma treatment; Drug: Group B: Control group

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Fayyum, Egypt
    • Fayoum University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A( Platelet-rich plasma group); Group A : patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment.	Drug: Group A :Platelet-rich plasma treatment; patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment
Placebo Comparator: Group B (control group); Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.	Drug: Group B: Control group; Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of healing rate of the wound (dehiscence)	One month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications : like drainage state , wound infection & bleeding	Complications : like drainage state , wound infection & bleeding	one month postoperative

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: treatment; Platelet-rich plasma; local injection; pilonidal sinus surgery
• Other Study ID Numbers: SCCREIRB-MEDICINFAYOM-GU-001-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be available if it needed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No