Application of Platelet-rich Plasma for the Management of Pilonidal Sinus Disease: A Randomized Clinical Trial of Different Treatment Modalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in Wound Healing
研究概览
简要总结
Pilonidal sinus disease is a common health-care problem, and surgical excision is the standard treatment modality. Controversy still exists regarding the best surgical technique for treating pilonidal disease in terms of minimizing disease recurrence and patient discomfort. In this study, the investigators compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.
详细描述
Pilonidal sinus disease is a health problem that has been attempted to be overcome by various treatment modalities since the first time it was described by Herbert Mayo in 1833. PS is usually diagnosed at 30 years of age, and the disease has a male predominance of 70-80%.
Common morbidities after the surgical treatment of PS are pain, loss of productive work hours and wound infections owing to long healing times. Therefore, the main goals of treatment are accelerating the healing time by decreasing pain and reducing the loss of productive work hours.
Local administration of platelet-rich plasma (PRP), which contains growth factors (Gfs), is a new method that has been reported to accelerate the healing process by 30-40% [2].
In this study, we aimed to investigate the effect of PRP on the pain score, wound-healing process and quality of life in the treatment process for PS disease.
METHOD
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic pilonial sinus disease
- •patients who had undergone abscess drainage and remained diseased after 8-10 weeks of drainage
排除标准
- •patients with acute abscess
- •patients with anemia
- •patients that use immunosuppressive drugs
- •patients with haematological malignancy
- •patients with bleeding disorder
- •patients with recurrent pilonida sinus disease
研究组 & 干预措施
Group A
The open surgical method and a moist gauze (with saline) were applied to patients in group A
干预措施: Open surgery (Procedure)
Group B
Open surgery and then PRP application were performed on patients in group B. After the cavity was filled with PRP, the wound was covered with a dry gauze.
干预措施: Open surgery (Procedure)
Group B
Open surgery and then PRP application were performed on patients in group B. After the cavity was filled with PRP, the wound was covered with a dry gauze.
干预措施: Platelet rich plasma administration (Other)
Group C
PRP was applied to the patients in group C after curettage of the sinus cavity. And again the wound was covered with a dry gauze.
干预措施: Minimal invasive surgery (Procedure)
Group C
PRP was applied to the patients in group C after curettage of the sinus cavity. And again the wound was covered with a dry gauze.
干预措施: Platelet rich plasma administration (Other)
结局指标
主要结局
Change in Wound Healing
时间窗: on postoperative days 0, 2, 3, 4 and 21
Wound healing rate was evaluated as recovery time per the cavity volume (day/cc). This showed the time required for each 1 cc volume of the cavity to be filled on a daily basis. After open or minimally invasive surgery, the volume of the cavity was measured with saline solution. The cavity was filled with saline and the volume of the cavity was determined by calculating how much fluid it took. The measurements were performed on postoperative days 0, 2, 3, 4 and 21. Therefore recovery time per the cavity volume was calculated according to the differences between the measurements.
次要结局
- Visual Analog Scale (VAS) score(at 24th hour, 48th hour, 96th hour, 120th hour and 3rd week)
- Short Form-36 and Nottingham Health Profile(before the surgery and in the postoperative 3rd week)
研究者
Cihangir Akyol
Associate Proffessor
Ankara University