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.
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..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
During wound closure, skin glue is not permitted as this interferes with the NPWT suction mechanism. The NPWT is a mesh-based dressing that will be applied following the transparent occlusive dressing as per the manufacturer's instructions. Patients assigned to NPWT will have their dressing connected to a suction device (ActiV.A.C.®, KCI) providing a constant negative pressure of 125mmHg and left in situ for between 5 and 7 days. The dressings and suction device are all CE-marked medical devices that are being used within their intended usage.
The wound will be closed as per the standard surgical technique and the operating surgeon's preference. Following wound closure of sarcoma tumour resection, standard absorbent dressing will be applied as per local protocols and the pre-op plan
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Clinical Outcome: The proportion of patients experiencing wound complications
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
Time frame: From surgery to 4 months post-op
Health Economic: The incremental cost per complication avoided
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.
Time frame: From surgery up to 4 months post-operatively
Change in EuroQoL-5 Dimensions (EQ-5D-5L) (Patient reported outcome measure of a patients perceptions of their overall health)
EQ-5D-5L is a validated questionnaire that measures an individual's perception of their overall health. The questionnaire will be completed either face-to-face, via postal questionnaires or via virtual appointments. EQ5D-5L has two components, the first is a visual analogue scale where participants rate their overall health one a scale of 0 (worst health state imagined) to 100 (best health state imagined). The second is a descriptive system that assess health across 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each with 5 responses ranging from "no problems" to "extreme problems". These responses provide an individuals health profile that can be converted into a single index score for reporting.
Time frame: 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)
The Toronto Extremity Salvage Score questionnaire contains 29 items related to various daily tasks and activities. Each item is rated on a 5-point scale, where 1 indicates "impossible to do" and 5 indicates "not at all difficult". The individual item scores are summed, and then the total score is divided by the maximum possible score (based on the number of applicable items) and multiplied by 100 to get a percentage.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 4 months post-operatively
Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)
The Musculoskeletal Tumour Society Score is typically administered by a clinician, who assesses the patient based on the six domains (pain, function, emotional acceptance, support, walking, and gait). Each domain is rated on a scale of 0 to 5, with 0 representing the worst possible outcome and 5 representing the best possible outcome. The individual domain scores are summed to create a total Musculoskeletal Tumour Society Score.
Time frame: Baseline and 4 months pot-operatively