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

NCT ID: NCT06206330

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Pilonidal Disease Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Platelet rich plasma group

In this group we applied Platelet rich plasma after the surgery. The surgery was fistulotomy and curettage.

Group Type ACTIVE_COMPARATOR

Platelet rich plasma

Intervention Type OTHER

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.

Control group

In this group, we did the surgery as fistulotomy and curettage but we did not apply a Platelet rich plasma.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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İsmail Oskay Kaya

OTHER_GOV

Sponsor Role lead

Responsible Party

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İsmail Oskay Kaya

proffesor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Diskapi Yildirim Beyazit Education And Research Hospital

Ankara, Altındag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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23.08.2021 118/01

Identifier Type: -

Identifier Source: org_study_id

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