SarcomaPhase 2SUNDIALNCT07048184
Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing
A Phase 2 study testing Negative Pressure Wound Therapy (NPWT) Dressings and Standard Absorbent Dressings in people with Sarcoma and Negative Pressure Therapy, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma, Negative Pressure Therapy, Wound Complication
- What is being tested?
- Negative Pressure Wound Therapy (NPWT) Dressings and Standard Absorbent Dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Glasgow Royal Infirmary
Glasgow, Scotland, G4 0SF
James Doonan, PhD, +4401412016535, james.doonan@glasgow.ac.uk
Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS
About this study
Official title: Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing: a Randomised Phase II 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.
Read the detailed 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..
- Conditions
- Sarcoma, Negative Pressure Therapy, Wound Complication
- Being tested
- Negative Pressure Wound Therapy (NPWT) Dressings, Standard Absorbent Dressings
- Keywords
- Sarcoma, Surgery, Wound Complication, Negative Pressure Wound Therapy, NPWT, Dressing, Tumour Resection
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (NPWT) DressingsDevice
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 DressingsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Absorbent Dressing | Active comparator | Standard Absorbent Dressings for wound closure Receives: Device: Standard Absorbent Dressings |
| Negative Pressure Wound Therapy Dressing | Experimental | NPWT Dressings will be used for wound closure Receives: Device: Negative Pressure Wound Therapy (NPWT) Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From surgery up to 4 months post-operatively
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 months pot-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Dec 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Solventum, Sarcoma UK, CRUK Trials unit Glasgow
- Responsible party
- Sponsor
- Investigators
- Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS, Principal investigator, Department of Trauma and Orthopaedics, Glagow Royal Infirmary, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048184
- Sponsor's protocol ID
- GN23ON401
- Acronym
- SUNDIAL
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.
PubMed 26313829Bedi M, King DM, DeVries J, Hackbarth DA, Neilson JC. Does Vacuum-assisted Closure Reduce the Risk of Wound Complications in Patients With Lower Extremity Sarcomas Treated With Preoperative Radiation? Clin Orthop Relat Res. 2019 Apr;477(4):768-774. doi: 10.1097/CORR.0000000000000371.
PubMed 30811365Ouyang Z, Trent S, McCarthy C, Cosker T, Stuart R, Pratap S, Whitwell D, White HB, Tao H, Guo X, Maxime Gibbons CL. The incidence, risk factors and outcomes of wound complications after preoperative radiotherapy and surgery for high grade extremity soft tissue sarcomas: A 14-year retrospective study. Eur J Surg Oncol. 2023 Nov;49(11):107086. doi: 10.1016/j.ejso.2023.107086. Epub 2023 Sep 16.
PubMed 37741042O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9.
PubMed 12103287Shields DW, Razii N, Doonan J, Mahendra A, Gupta S. Closed incision negative pressure wound therapy versus conventional dressings following soft-tissue sarcoma excision: a prospective, randomized controlled trial. Bone Jt Open. 2021 Dec;2(12):1049-1056. doi: 10.1302/2633-1462.212.BJO-2021-0103.R1.
PubMed 34905941Nandra R, Hwang N, Matharu GS, Reddy K, Grimer R. One-year mortality in patients with bone and soft tissue sarcomas as an indicator of delay in presentation. Ann R Coll Surg Engl. 2015 Sep;97(6):425-33. doi: 10.1308/003588415X14181254790284. Epub 2015 Aug 14.
PubMed 26274756
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing: a Randomised Phase II Trial
- ClinicalTrials.gov ID
- NCT07048184
- Acronym / sponsor ID
- SUNDIAL / GN23ON401
- Conditions
- Sarcoma, Negative Pressure Therapy, Wound Complication
- Keywords
- Sarcoma, Surgery, Wound Complication, Negative Pressure Wound Therapy, NPWT, Dressing, Tumour Resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Solventum, Sarcoma UK, CRUK Trials unit Glasgow
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Absorbent Dressing | Active comparator | Device: Standard Absorbent DressingsStandard Absorbent Dressings for wound closure |
| Negative Pressure Wound Therapy Dressing | Experimental | Device: Negative Pressure Wound Therapy (NPWT) DressingsNPWT Dressings will be used for wound closure |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) DressingsDuring 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. | Device | Negative Pressure Wound Therapy Dressing |
| Standard Absorbent DressingsThe 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 | Device | Standard Absorbent Dressing |
Primary outcome
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
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.
3 secondary outcomes
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
Change in Toronto Extremity Salvage Score (Patient-reported outcome measure of function after limb salvage procedures)
Time frame: Baseline and 4 months post-operatively
Change in Musculoskeletal Tumour Society Score (Clinician-led patient questionnaire used to assess functional outcomes)
Time frame: Baseline and 4 months pot-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 26313829Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.
- Background: PubMed 30811365Bedi M, King DM, DeVries J, Hackbarth DA, Neilson JC. Does Vacuum-assisted Closure Reduce the Risk of Wound Complications in Patients With Lower Extremity Sarcomas Treated With Preoperative Radiation? Clin Orthop Relat Res. 2019 Apr;477(4):768-774. doi: 10.1097/CORR.0000000000000371.
- Background: PubMed 37741042Ouyang Z, Trent S, McCarthy C, Cosker T, Stuart R, Pratap S, Whitwell D, White HB, Tao H, Guo X, Maxime Gibbons CL. The incidence, risk factors and outcomes of wound complications after preoperative radiotherapy and surgery for high grade extremity soft tissue sarcomas: A 14-year retrospective study. Eur J Surg Oncol. 2023 Nov;49(11):107086. doi: 10.1016/j.ejso.2023.107086. Epub 2023 Sep 16.
- Background: PubMed 12103287O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9.
- Background: PubMed 34905941Shields DW, Razii N, Doonan J, Mahendra A, Gupta S. Closed incision negative pressure wound therapy versus conventional dressings following soft-tissue sarcoma excision: a prospective, randomized controlled trial. Bone Jt Open. 2021 Dec;2(12):1049-1056. doi: 10.1302/2633-1462.212.BJO-2021-0103.R1.
- Background: PubMed 26274756Nandra R, Hwang N, Matharu GS, Reddy K, Grimer R. One-year mortality in patients with bone and soft tissue sarcomas as an indicator of delay in presentation. Ann R Coll Surg Engl. 2015 Sep;97(6):425-33. doi: 10.1308/003588415X14181254790284. Epub 2015 Aug 14.
- UK S. Sarcoma IncidenceLink provided by the sponsor.
- EUROQOL. EQ-5D-5L User Guide 2023Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS principal investigator
Department of Trauma and Orthopaedics, Glagow Royal Infirmary, NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Negative Pressure Wound Therapy (NPWT) Dressings and Standard Absorbent Dressings in people with Sarcoma and Negative Pressure Therapy, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen Soulis, MA (+4401413017184, eileen.soulis@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome: The proportion of patients experiencing wound complications (time frame: From surgery to 4 months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048184, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.