Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Wound healing time
研究概览
简要总结
The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation.
The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years of age and older
- •Symptomatic complex or recurrent pilonidal sinus disease
- •Planned for surgical treatment
- •Signed informed consent
排除标准
- •Insufficient understanding of the Dutch language or otherwise unable to give consent
结局指标
主要结局
Wound healing time
时间窗: The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned
Time to wound healing (in days), this will be self reported by patients when the skin is completely closed, and will be validated through clinical assessment by the surgeon.
次要结局
- Return to normal activities(The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned)
研究者
Max Goudberg
MD, PhD candidate
Albert Schweitzer Ziekenhuis, Netherlands