An interventional study of Platelet rich plasma in Pilonidal Disease and Pilonidal Sinus, sponsored by İsmail Oskay Kaya. Completed at 1 site in Turkey. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by İsmail Oskay Kaya · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 140 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →This is the only study on the registry with İsmail Oskay Kaya as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group we applied Platelet rich plasma after the surgery. The surgery was fistulotomy and curettage.
Other: Platelet rich plasma
In this group, we did the surgery as fistulotomy and curettage but we did not apply a 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.
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.
Time frame: up to two months
infection
presence of infection after surgery.
Time frame: up to two months
hematoma
presence of hematoma after surgery.
Time frame: 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"
Time frame: 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
Time frame: up to two months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Nov 2022, 12 months.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 12 months is below that.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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