Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06206330 |
| Other study ID # |
23.08.2021 118/01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
