Actively Recruiting
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
Led by Centre Leon Berard · Updated on 2025-08-08
166
Participants Needed
15
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years at the day of consenting to the study
- Patients with primary STS of the limb or trunk treated with preoperative external radiation therapy decided in multidisciplinary board
- Intent to cure resection required for STS planned between 3 to 8 weeks after the end of RT
- Planned primary wound closure, including local or distant jambeau
- Ability to understand and willingness for follow-up visits
- Covered by a medical insurance
- Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
You will not qualify if you...
- Known hypersensibility to silver
- Patients with diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor (only bone tumors excluded; soft tissue tumors allowed)
- Patient in relapse setting
- Patient requiring a surgical revision after R1 or R2 resection
- Planned blade drainage
- Planned no wound-closure and skin graft after resection
- Patient requiring authorship or curators or patient deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
CHU Nantes
Nantes, Pays de Loire, France, 44093
Actively Recruiting
2
Centre Leon Berard
Lyon, Rhône-Alpes Auvergne, France, 69008
Actively Recruiting
3
Institut de Cancérologie de l'Ouest - Pays de Loire
Angers, France, 49055
Actively Recruiting
4
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
5
CHRU Tours Hôpital Trousseau
Chambray-lès-Tours, France, 37170
Actively Recruiting
6
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
7
Centre Georges François Leclerc
Dijon, France, 21000
Actively Recruiting
8
Centre Oscar Lambert
Lille, France, 59000
Actively Recruiting
9
CHU Limoges
Limoges, France, 87042
Actively Recruiting
10
Institut du Cancer de Montpellier
Montpellier, France, 34090
Actively Recruiting
11
Institut Curie
Paris, France, 75005
Not Yet Recruiting
12
APHP Hôpital Cochin
Paris, France, 75014
Not Yet Recruiting
13
CHU Rennes
Rennes, France, 35033
Not Yet Recruiting
14
IUCT Oncopole
Toulouse, France, 31100
Actively Recruiting
15
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
Research Team
F
François Gouin, MD, Chirurgien
CONTACT
S
Séverine METZGER, Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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