Effect of Platelet Rich Plasma (PRP) on Healing Time in Patients Following Pilonidal Sinus Surgery

NCT06206330 | Completed

• 1 other identifier: 23.08.2021 118/01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Our study was planned as a prospective controlled randomized study. The study was started after the ethics committee approval received from Dışkapı Yıldırım Beyazıt Training and Research Hospital. (23.08.2021 118/01). Two groups of patients were planned in parallel. In the treatment of pilonidal sinus disease, in patients operated on with the fistulotomy and curettage technique, one group was followed up with classical dressing, while the other group was followed up with PRP (platelet-rich-plasma) and classical dressing. Wound infection, hematoma, length of hospital stay, recurrence, pain in the first postoperative week, and time to complete epithelialization of the wound (in days) were evaluated between the two groups.

Conditions

Pilonidal Disease; Pilonidal Sinus

Keywords

Platelet rich plasma(PRP); Pilonidal sinus surgery; Healing time

Outcome Measures

Primary Outcomes (1)

• Platelet rich plasma accelerate the epithelialization of the wound after pilonidal sinus surgery

  After the application of PRP the patients examined at the postoperative 2-4-6-10-15-20-25-30-35-40-45-50-55 days for the wound closure. The day of total epithelialization was noted.

  up to two months

Secondary Outcomes (4)

• infection

  up to two months

• hematoma

  up to two months

• Pain intensity

  up tp two months

• recurrence

  up to two months

Study Arms (2)

Platelet rich plasma group

ACTIVE COMPARATOR

In this group we applied Platelet rich plasma after the surgery. The surgery was fistulotomy and curettage.

Other: Platelet rich plasma

Control group

NO INTERVENTION

In this group, we did the surgery as fistulotomy and curettage but we did not apply a Platelet rich plasma.

Interventions

Platelet rich plasma OTHER

After application of platelet rich plasma after surgery, the patients have examined for infection, hematoma, pain, recurrence and the time of epithelialization of the wound.

Platelet rich plasma group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients diagnosed with pilonidal sinus disease in our hospital between November 2021 and November 2022

You may not qualify if:

• Patients under 18 years of age
• Acute pilonidal abcess
• Recurrent disease
• Anemic patients (Hg \< 10 mg/dl)
• Thrombocytopenic patients (Plt˂10⁶/ml)
• Patients with a history of radiotherapy-chemotherapy
• Diabetes Mellitus
• Patients using steroids

Sponsors & Collaborators

• İsmail Oskay Kaya: lead

Study Sites (1)

Diskapi Yildirim Beyazit Education And Research Hospital

Ankara, Altındag, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: proffesor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 16, 2024
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)