About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous surgery to planned surgical field
Contra-indication to surgical excision of the tumour
Disseminated malignancy on pre-op radiological imaging
Post-radiation sarcoma
Trial design
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy (NPWT) Dressings
DeviceDuring 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.
Standard Absorbent Dressings
DeviceThe 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
Treatment groups
Trial outcomes
Primary outcomes
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
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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NHS Greater Glasgow and Clyde
Lead sponsor
University of Glasgow
Collaborator
Solventum
Collaborator
Sarcoma UK
Collaborator
CRUK Trials unit Glasgow
Collaborator
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