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

İ

İsmail Oskay Kaya

Status

Completed

Conditions

Pilonidal Disease
Pilonidal Sinus

Treatments

Other: Platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT06206330
23.08.2021 118/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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