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

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06206330
• Other study ID #: 23.08.2021 118/01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2024
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease
• Pilonidal Sinus

Intervention

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.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Education And Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ismail Oskay Kaya

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	infection	presence of infection after surgery.	up to two months
Secondary	hematoma	presence of hematoma after surgery.	up to two months
Secondary	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
Secondary	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