SarcomaNCT02901405
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
A study testing Negative Pressure Wound Therapy (ActivVAC, KCI) and Standard dressings in people with Sarcoma and Wound Infection, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma, Wound Infection
- What is being tested?
- Negative Pressure Wound Therapy (ActivVAC, KCI) and Standard dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2016to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults undergoing primary soft tissue sarcoma excision which is primarily closed.
Who cannot join
- Unable to consent
- Children
- Post radiation sarcomas or sarcoma in presence of active infection
- Multiple metastatic disease
- Presence of Endoprosthesis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
About this study
Official title: Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings
Read the detailed description
Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.
Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation
- Conditions
- Sarcoma, Wound Infection
- Being tested
- Negative Pressure Wound Therapy (ActivVAC, KCI), Standard dressings
- Keywords
- sarcoma, infection, negative pressure
- Medical subject headings
- Sarcoma, Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (ActivVAC, KCI)Device
Standard dressingsDevice
Current absorbent dressing is 'tegaderm with absorbent pad' (3M)
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | 120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound. Receives: Device: Negative Pressure Wound Therapy (ActivVAC, KCI) |
| Standard dressings | Active comparator | Absorbant dressings applied in a standard fashion, i.e. only changed as necessary Receives: Device: Standard dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (proportion)
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
Measured: 30 days
Secondary outcomes (4)
Time to wound dryness (nominal scale)
Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)
Measured: 30 days
Delay to discharge form hospital (nominal scale)
Number of additional hospital stays attributable to wound issues
Measured: 30 days
Adverse events (count)
Number of unanticipated events
Measured: 30 days
Cost analysis (comparative nominal scale in £)
Cost analysis to evaluate potential offset of costs for NPWT
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start18 Oct 2016
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Why it stopped: The study was unable to meet recruitment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Gupta, MBBS, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901405
- Sponsor's protocol ID
- GN15OR558
- Status last verified
- Nov 2021
- First submitted
- 1 Sep 2016
- Last updated
- 26 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
- ClinicalTrials.gov ID
- NCT02901405
- Acronym / sponsor ID
- GN15OR558
- Conditions
- Sarcoma, Wound Infection
- Keywords
- sarcoma, infection, negative pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was unable to meet recruitment targets
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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.
This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings
Detailed description
Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.
Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound Therapy (ActivVAC, KCI)120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound. |
| Standard dressings | Active comparator | Device: Standard dressingsAbsorbant dressings applied in a standard fashion, i.e. only changed as necessary |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing primary soft tissue sarcoma excision which is primarily closed.
Key exclusion criteria (5 listed)
- Unable to consent
- Children
- Post radiation sarcomas or sarcoma in presence of active infection
- Multiple metastatic disease
- Presence of Endoprosthesis
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 (ActivVAC, KCI) | Device | Negative Pressure Wound Therapy |
| Standard dressingsCurrent absorbent dressing is 'tegaderm with absorbent pad' (3M) | Device | Standard dressings |
Primary outcome
Surgical Site Infection (proportion)
Time frame: 30 days
As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines
4 secondary outcomes
Time to wound dryness (nominal scale)
Time frame: 30 days
Delay to discharge form hospital (nominal scale)
Time frame: 30 days
Adverse events (count)
Time frame: 30 days
Cost analysis (comparative nominal scale in £)
Time frame: 30 days
Results and safety
The study was stopped early (reason given: The study was unable to meet recruitment targets). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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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. This study is not recruiting at the moment.
Sanjay Gupta, MBBS principal investigator
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 study testing Negative Pressure Wound Therapy (ActivVAC, KCI) and Standard dressings in people with Sarcoma and Wound Infection, 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Nov 2021. 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.
Are results available for this study?
The study was stopped early (reason given: The study was unable to meet recruitment targets). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (proportion) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2021.