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

NCT05944913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-08-08

No results posted yet for this study

Summary

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)

Conditions

  • Soft Tissue Sarcoma

Interventions

DEVICE

Prevena

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.

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • François Gouin, MD, Chirurgien · Centre Leon Berard

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944913 on ClinicalTrials.gov