Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

Sponsor
Centre Leon Berard
Study ID
NCT05944913
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • Prevena — DEVICE
    PREVENA™ is a CE-marked class IIa medical device. The PREVENA™ Incision Management System is also intended to manage the environment of closed surgical incisions and surround intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision.

Study Details

This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)

Key Dates

First listed
Jul 13, 2023
Start date
Aug 3, 2023
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Arm A : Surgery for STS and prevena
    The surgery for the STS lesion will be performed according to standard practices. PREVENA™ Incision Management System should be applied immediately post-surgery to clean surgically closed wounds. It should be continuously applied for a minimum of 2 days and up to a maximum of 7 days (as per PREVENA user manual)
  • No Intervention: Arm B : Surgery for STS and standard postoperative wound management
    The surgery for the STS lesion will be performed according to standard practices. The dressing and drainage of the wound will be performed according to usual practices, with the exception of negative pressure dressings.

Primary Outcome Measure

The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS [ Time Frame: Within the 3-month postoperative period. ]

Central Contacts

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