Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorNHS Greater Glasgow and Clyde

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Negative Pressure Wound Therapy (NPWT) Dressings

    Device

    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.

  • Standard Absorbent Dressings

    Device

    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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Standard Absorbent DressingActive comparator 1 intervention
Group B: Negative Pressure Wound Therapy DressingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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.

Time frame
Baseline and 4 months post-operatively
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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