Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing
NCT ID: NCT07048184
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
94 participants
INTERVENTIONAL
2025-12-01
2027-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Absorbent Dressing
Standard Absorbent Dressings for wound closure
Standard Absorbent Dressings
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
Negative Pressure Wound Therapy Dressing
NPWT Dressings will be used for wound closure
Negative Pressure Wound Therapy (NPWT) Dressings
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.
Interventions
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Negative Pressure Wound Therapy (NPWT) Dressings
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
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
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* Aged 16 years or over
* Able, and willing, to adhere to scheduled trial procedures and visit schedule
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Solventum
INDUSTRY
Sarcoma UK
UNKNOWN
CRUK Trials unit Glasgow
UNKNOWN
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Sanjay Gupta, MBBS, MRCS, MSc, MPhil, FRCS
Role: PRINCIPAL_INVESTIGATOR
Department of Trauma and Orthopaedics, Glagow Royal Infirmary, NHS Greater Glasgow and Clyde
Locations
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Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bedi 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.
Ouyang 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.
O'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.
Shields 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.
Nandra 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.
Related Links
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UK S. Sarcoma Incidence
EUROQOL. EQ-5D-5L User Guide 2023
Other Identifiers
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GN23ON401
Identifier Type: -
Identifier Source: org_study_id
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