Sarcoma Surgery Wound Complications Comparing Usual Versus Negative Pressure Dressing

Sponsor
NHS Greater Glasgow and Clyde
Study ID
NCT07048184
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Negative Pressure Therapy
  • Sarcoma
  • Wound Complication

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jul 2, 2025
Start date
Dec 1, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Absorbent Dressing
    Standard Absorbent Dressings for wound closure
  • Experimental: Negative Pressure Wound Therapy Dressing
    NPWT Dressings will be used for wound closure

Primary Outcome Measure

Clinical Outcome: The proportion of patients experiencing wound complications [ Time Frame: From surgery to 4 months post-op ]

Central Contacts

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