Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07048184

Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sarcoma Negative Pressure Therapy Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Wound Complication

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

Location contact

James Doonan, PhD

CONTACT

[email protected]

+4401412016535

Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS

PRINCIPAL_INVESTIGATOR

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Clinical Outcome: The proportion of patients experiencing wound complications

    Time frame: 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

  2. Health Economic: The incremental cost per complication avoided

    Time frame: 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.

Secondary outcomes

  1. Change in EuroQoL-5 Dimensions (EQ-5D-5L) (Patient reported outcome measure of a patients perceptions of their overall health)

    Time frame: Baseline, 28 day post-op and 4 month post-op

    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.

  2. Change in Toronto Extremity Salvage Score (Patient-reported outcome measure of function after limb salvage procedures)

    Time frame: Baseline and 4 months post-operatively

    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.

  3. Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)

    Time frame: Baseline and 4 months pot-operatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eileen Soulis, MA

CONTACT

[email protected]

+4401413017184

James Doonan, PhD

CONTACT

[email protected]

+44 0141 201 6535

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • CRUK Trials unit Glasgow
  • Sarcoma UK
  • Solventum
  • University of Glasgow

Registry information

Official study title

Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing: a Randomised Phase II Trial

Acronym: SUNDIAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.