Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing: a Randomised Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Clinical Outcome: The proportion of patients experiencing wound complications
研究概览
简要总结
To compare the differences in clinical outcomes and health economics between standard absorbent dressings versus Negative Pressure Wound Therapy dressings following the surgical resection of sarcoma tumours.
详细描述
The investigators propose to undertake a randomised controlled trial comparing standard absorbent dressings with Negative Pressure Wound Therapy (NPWT) dressings in the wound management following resection of sarcoma tumours. By using, NPWT in sarcoma patients the investigators aim to reduce the number of patients experiencing wound complications compared to those who receive standard absorbent dressings. 94 participants will be recruited over 12 months and randomised in a 1:1 ratio to receive either the standard or NPWT dressings. The primary aim will be to determine whether there is a clinically significant difference in wound complications between standard dressings and NPWT dressings over a four-month post-op period. The investigators will assess the patient's wound for signs of infection, dehiscence and other potential complications, and document the incidence and severity of complications. Researchers will also collect the Musculoskeletal Tumour Society Score (MSTS) and Toronto Extremity Salvage Score (TESS) at pre-op and 4 months post-op to understand how the dressings may have impacted function following recovery. In addition, health economic data will also be captured in the form for ED-5D-5L and questionnaires that will focus on the economic impact of surgery and potential wound complications on a patient return to work.
Wound complications following sarcoma tumour surgery can be traumatic for patients during their recovery and postpone subsequent chemotherapy treatments, as well as being an expensive burden to the NHS. NPWT dressings may potentially offer benefits to both patients and the NHS yet there is insufficient data available to support widespread use of this product in sarcoma patients. It is the investigators belief that NPWT is used because anecdotally it is believed to be better than standard absorbent dressings. However, there is a clear lack of robust evidence to support this idea, and the investigator aim to address this by undertaking this study..
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
盲法说明
This study will be fully unblinded due to the nature of the wound dressings used.
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
- •Sarcoma of the upper/lower limb or torso requiring wide local excision, planned marginal excision or amputation
- •Able to provide informed consent
- •Aged 16 years or over
- •Able, and willing, to adhere to scheduled trial procedures and visit schedule
排除标准
- •Previous surgery to planned surgical field
- •Contra-indication to surgical excision of the tumour
- •Disseminated malignancy on pre-op radiological imaging
- •Post-radiation sarcoma
- •Allergy to adhesive dressing
- •Subjects who, in the opinion of the PI, will be unable to comply with follow-up
结局指标
主要结局
Clinical Outcome: The proportion of patients experiencing wound complications
时间窗: From surgery to 4 months post-op
Measured as the proportion of patients with 1 or more wound complications experienced between surgery and the end of post-surgery treatment (4 months after surgery). This will be a binary endpoint for each patient (yes/no). Types of wound complication include: * Superficial and deep surgical site infections * Dehiscence: partial and complete cases * Other
Health Economic: The incremental cost per complication avoided
时间窗: From surgery up to 4 months post-operatively
Measured using a breadth of health economic data collected during the course of the study to capture the cost of complications, readmissions, EQ5D-5L questionnaire, recovery times and return to work.
次要结局
- Change in EuroQoL-5 Dimensions (EQ-5D-5L) (Patient reported outcome measure of a patients perceptions of their overall health)(Baseline, 28 day post-op and 4 month post-op)
- Change in Toronto Extremity Salvage Score (Patient-reported outcome measure of function after limb salvage procedures)(Baseline and 4 months post-operatively)
- Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)(Baseline and 4 months pot-operatively)
- Change in EuroQoL-5 Dimensions (EQ-5D-5L) (Patient reported outcome measure of a patients perceptions of their overall health)(Baseline, 28 day post-op and 4 month post-op)
- Change in Toronto Extremity Salvage Score (Patient-reported outcome measure of function after limb salvage procedures)(Baseline and 4 months post-operatively)
- Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)(Baseline and 4 months pot-operatively)