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

The Effect Of Prp (Platelet-Rıch-Plasma) Application On Wound Healing In The Treatment Of Pilonidal Sinus Disease Using Unroofing And Curettage Technique

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus; Pilonidal Disease
• Intervention / Treatment: Other: Platelet rich plasma

Detailed Description

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.

A total of 140 patients, male and female, diagnosed with pilonidal sinus disease in our hospital between November 2021 and November 2022 were included in the study. Patients with acute pilonidal sinus abscess were excluded from the study, but chronic PS(pilonidal sinus) patients who had previously undergone abscess drainage were included in the study.

Patients under 18 years of age, relapsed patients, anemic patients (Hg < 10 mg/dl), thrombocytopenic patients (Plt˂10⁶/ml), patients with a history of radiotherapy-chemotherapy, patients with diabetes and patients using steroids were excluded from the study.

Randomization was performed using the PASS computer program, and according to this randomization, fistulotomy and curettage technique (n=70) was applied to one group and fistulotomy and curettage + PRP (n=70) was applied to the other group.

Demographic information, family history, smoking, presence of abscess drainage, post-drainage antibiotic use, comorbidities, BMI, symptom duration, phenol application, laser epilation, number of sinus pits, presence of secondary orifice, basal PLT(platelet) count, size of the defect after sinus excision, wound infection, hematoma, length of hospital stay, presence of recurrence, pain in the first postoperative week, and time to complete epithelialization were evaluated.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındag
    • Ankara, Altındag, Turkey, 06010
      • Diskapi Yildirim Beyazit Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet rich plasma group; In this group we applied Platelet rich plasma after the surgery. The surgery was fistulotomy and curettage.	Other: Platelet rich plasma; 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.
No Intervention: Control group; In this group, we did the surgery as fistulotomy and curettage but we did not apply a Platelet rich plasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection	presence of infection after surgery.	up to two months
hematoma	presence of hematoma after surgery.	up to two months
Pain intensity	Pain intensity of patients measured by Visual analogue scale (VAS) score. 0 represents "no pain" and 10 "pain as bad as it could possibly be"	up tp two months
recurrence	Recurrence of the pilonidal disease of the patient is presence of pits in the previous surgical area and also presence a tender mass or sinus draining mucoid, purulent, and/or bloody fluid	up to two months

Collaborators and Investigators

• Sponsor: İsmail Oskay Kaya

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Healing time; Platelet rich plasma(PRP); Pilonidal sinus surgery
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: 23.08.2021 118/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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