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

Not Applicable

Completed

• Conditions: Pilonidal Disease; Pilonidal Sinus

• Registration Number: NCT06206330
• Lead Sponsor: İsmail Oskay Kaya

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.

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 Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Study First Submitted: 2023-12-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Platelet rich plasma accelerate the epithelialization of the wound after pilonidal sinus surgery	up to two months	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.

Secondary Outcome Measures

Name	Time	Method
infection	up to two months	presence of infection after surgery.
hematoma	up to two months	presence of hematoma after surgery.
Pain intensity	up tp two months	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"
recurrence	up to two months	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

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Education And Research Hospital; 🇹🇷 Ankara, Altındag, Turkey