NCT07567586

Brief Summary

The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

April 25, 2026

Last Update Submit

April 30, 2026

Conditions

Pilonidal Sinus DiseasePlatelet-rich PlasmaTreatment

Keywords

treatmentpilonidal sinus surgeryPlatelet-rich plasmalocal injection

Outcome Measures

Primary Outcomes (1)

  • Incidence of healing rate of the wound (dehiscence)

    One month postoperative

Secondary Outcomes (1)

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

    one month postoperative

Study Arms (2)

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.

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.

Drug: Group B: Control group

Interventions

Group A :Platelet-rich plasma treatmentDRUG

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

Group A( Platelet-rich plasma group)
Group B: Control groupDRUG

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

Group B (control group)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 5, 2026

Study Start

March 30, 2023

Primary Completion

March 30, 2025

Study Completion

May 30, 2025

Last Updated

May 5, 2026

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

EG(1)