Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of complete wound healed and not healed after 8 postoperative days
研究概览
简要总结
Pilonidal disease is morbid condition of young productive population, that could impair quality of life with high cost for health care system. No consensus exists on optimal surgical treatment, even if several techniques have been proposed. In this preliminary experimental case-control study the investigators compared excision by knife and diathermy with the aim to investigate if wound dehiscence could be related to heat spreading during excision of the sinus.
详细描述
Between January 2017 and February 2018, 29 patients underwent to sinus excision. The investigators considered 16 sinus excision performed by diathermy as a case group (named "Hot" group) and the last 13 procedures performed by knife as control group (named "Cold" group). Temperature data were recorded for both group. Follow-up was carried out until complete healing. Were considered primary and secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 52 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients between 14 and 65 years old,
- •primary, non recurrent pilonidal disease
- •midline and intergluteal location
- •spinal anesthesia
- •dimension no more than 5 cm in length, primary closure performed
排除标准
- •age < 14 and > 65 years old,
- •secondary fistulous tracts or lateral developing/cutaneous opening
- •dimension over 5 cm in length,
- •local anesthesia employ
- •smoker and obese patients (BMI> 25 kg/m2)
- •diabetic and coagulopathies affected one
- •flogged or acute or infected or abscessed forms
- •ASA score > IV,
- •normal range WBC and Hb preoperative values.
结局指标
主要结局
Number of complete wound healed and not healed after 8 postoperative days
时间窗: Up to 4 weeks
We established as primary outcomes, the number of wound completely healed after 8-12 days
次要结局
- types of complications (Dindo-Clavien)(follow-up 12 months)
- post-operative pain in first postoperative day (analogue pain score, VAS)(7 days)
- operative time for complete excision of the sinus (minutes)(minutes (range 0-30 minutes))