The Effect Of Prp (Platelet-Rıch-Plasma) Application On Wound Healing In The Treatment Of Pilonidal Sinus Disease Using Unroofing And Curettage Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Platelet rich plasma accelerate the epithelialization of the wound after pilonidal sinus surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients diagnosed with pilonidal sinus disease in our hospital between November 2021 and November 2022
排除标准
- •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
结局指标
主要结局
Platelet rich plasma accelerate the epithelialization of the wound after pilonidal sinus surgery
时间窗: 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.
次要结局
- infection(up to two months)
- hematoma(up to two months)
- Pain intensity(up tp two months)
- recurrence(up to two months)
研究者
İsmail Oskay Kaya
proffesor
Diskapi Yildirim Beyazit Education and Research Hospital