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Completed

NCT Number: NCT06206330

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Yildirim Beyazit Education And Research Hospital

Ankara, Altındag, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma

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.

Primary outcomes

  1. Platelet rich plasma accelerate the epithelialization of the wound after pilonidal sinus surgery

    Time frame: up to two months

    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.

Secondary outcomes

  1. infection

    Time frame: up to two months

    presence of infection after surgery.

  2. hematoma

    Time frame: up to two months

    presence of hematoma after surgery.

  3. Pain intensity

    Time frame: up tp two months

    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"

  4. recurrence

    Time frame: up to two months

    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

Sponsors and collaborators

Lead sponsor

İsmail Oskay Kaya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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