Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing (SUNDIAL)

NHS Trust

Status and phase: Not yet enrolling; Phase 2

Conditions: Sarcoma; Wound Complication; Negative Pressure Therapy

Treatments: Device: Standard Absorbent Dressings; Device: Negative Pressure Wound Therapy (NPWT) Dressings

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07048184

GN23ON401

Details and patient eligibility

About

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.

Full description

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..

Enrollment: 94 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Standard Absorbent Dressing

Active Comparator group

Description:

Standard Absorbent Dressings for wound closure

Treatment:

Device: Standard Absorbent Dressings

Negative Pressure Wound Therapy Dressing

Experimental group

Description:

NPWT Dressings will be used for wound closure

Treatment:

Device: Negative Pressure Wound Therapy (NPWT) Dressings