Excision and Negative Pressure Wound Therapy Versus Excision and Leaving Open With Standard Wound Care for Management of Chronic Pilonidal Sinus Disease - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Time to complete wound healing
研究概览
简要总结
This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).
详细描述
Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males.
PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery.
The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.
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
- None
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
- •i) They are aged 18 years or older
- •ii) They are undergoing elective pilonidal sinus excision without primary closure
排除标准
- •i) They are unable to adhere to protocol requirements e.g. questionnaire completion
- •ii) They are undergoing emergency drainage for a pilonidal abscess
- •iii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft
- •iv) They have underlying osteomyelitis
- •v) They have underlying fistulating disease e.g. Crohn's
研究组 & 干预措施
Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy.
干预措施: Negative Pressure Wound Therapy (Device)
Standard Wound dressing
After the skin is closed, the wound is covered using sterile standard gauze dressing.
干预措施: Negative Pressure Wound Therapy (Device)
结局指标
主要结局
Time to complete wound healing
时间窗: 6 months post surgery
Number of days to complete epithelialisation or closure of the wound without any discharge, drainage, scab, and/or the requirement for further dressing. The quality of wound healing will be assessed using a validated patient and observer reported scar assessment tool-POSAS.
次要结局
- Measure of post operative pain(6 months post surgery)
- Measure of post operative complications(6 months post surgery)
- Measure of quality of life(6 months post surgery)
- To investigate resource use(6 months post surgery)
- To compare recurrence rates(6 months post surgery)
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)(6 months)
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)(6 months)
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)(6 Months)
- Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings(6 Months)
- Visual pain score questionnaire(3 Months)