信封：藏毛窦手术后的伤口护理 (ENVELOP)
切除和负压伤口治疗与切除和开放标准伤口护理治疗慢性藏毛窦疾病的比较 - 一项随机对照试验
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).
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sean T Martin
- 电话号码：(01) 261 4037
- 邮箱：seanmartin@rcsi.ie
研究联系人备份
- 姓名：Eanna Ryan
- 电话号码：(01) 261 4037
- 邮箱：eannaryan@rcsi.com
学习地点
-
-
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Castlebar、爱尔兰
- 招聘中
- Mayo University Hospital
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接触：
- Kevin Barry
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Dublin、爱尔兰
- 招聘中
- Tallaght University Hospital
-
接触：
- Dara Kavanagh
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Dublin、爱尔兰、D09V2N0
- 招聘中
- Beaumont Hospital
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接触：
- John Burke
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Dublin、爱尔兰
- 招聘中
- St James's Hospital
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接触：
- Michael Kelly
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Dublin、爱尔兰
- 招聘中
- St Michael's Hospital, Dún Laoghaire
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接触：
- Helen Heneghan
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Dublin、爱尔兰
- 招聘中
- St Vincent's Univeristy Hospital
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接触：
- Eanna Ryan
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Kilkenny、爱尔兰
- 招聘中
- St. Luke's Hospital
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接触：
- Cathy Cronin
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Limerick、爱尔兰
- 招聘中
- University Hospital Limerick
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接触：
- Colin Peirce
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Tullamore、爱尔兰
- 招聘中
- Midlands University Hospital
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接触：
- Sean Johnston
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Waterford、爱尔兰
- 招聘中
- University Hospital Waterford
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接触：
- Peter Neary
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
i) They are aged 18 years or older
ii) They are undergoing elective pilonidal sinus excision without primary closure
Exclusion Criteria:
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 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy. |
Following elective excision of chronic pilonidal sinus disease with the wound left open, NPWT is applied in theatre using a polyurethane foam-based system (e.g. VAC, Renasys-GO, Prevena or equivalent) cut to fit the wound cavity, sealed with an adhesive drape and connected to a portable pump at -125 mmHg continuous pressure. Dressings are changed every 48-72 hours in clinic until granulation reaches skin level, followed by standard dressings until epithelialisation. |
|
有源比较器：Standard wound care (SWC)
Following excision, the wound is left open (no primary closure) and managed with standard dressings according to local protocol, with wound healing by secondary intention. |
Standard wound care |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to complete wound healing
大体时间：Up to 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. |
Up to 6 months post surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure of post operative pain
大体时间：Day of surgery, 28 days post surgery & 3 months post surgery
|
Pain measured by visual analogue pain scale (0 = no pain, 10 = worst pain) at rest, on walking and on sitting |
Day of surgery, 28 days post surgery & 3 months post surgery
|
|
Measure of post operative complications
大体时间：6 months post surgery
|
Post-operative complications, including surgical site infection (CDC criteria), seroma, abscess, readmission and return to theatre. |
6 months post surgery
|
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To compare recurrence rates
大体时间：6 months post surgery
|
To compare the 6-month recurrence rates (recurrence being defined as the development of a new sinus or abscess within the natal cleft occurring after wound healing had been achieved) between the NPWT and SWC Groups |
6 months post surgery
|
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Cost-effectiveness
大体时间：6 months post surgery
|
Within-trial cost-utility analysis from health-system and patient perspectives, expressed as incremental cost per QALY gained (QALYs from EQ-5D-5L, area under the curve). Resource use includes hospital and community contacts, dressing changes, complications, readmissions and returns to theatre, valued at Irish unit costs; patient costs and productivity losses via CoPaQ. |
6 months post surgery
|
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Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
大体时间：Baseline, 1 month, 3 months & 6 months
|
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Index values derived using the EQ-5D-5L value set specified in the Statistical Analysis Plan (Irish value set where available). |
Baseline, 1 month, 3 months & 6 months
|
|
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
大体时间：28 days, 3 months, 6 months
|
The POSAS is made up of two scales: the patient and observer scales each comprise six items scored 1 to 10; each scale is summed (6 = normal, 60 = worst) and reported separately. |
28 days, 3 months, 6 months
|
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Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
大体时间：28 days, 3 months, 6 months
|
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
28 days, 3 months, 6 months
|
合作者和调查者
调查人员
- 首席研究员：Sean T Martin、St. James's Hospital, Ireland
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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