Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
TPN-RAD
Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy
1 other identifier
interventional
166
1 country
15
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
August 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 8, 2025
August 1, 2025
3 years
June 26, 2023
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
Assessed by major wound complications rate
Within the 3-month postoperative period.
Secondary Outcomes (8)
Three month deep infection rate
At 3 months post-surgery visit
Three months secondary surgery for wound healing problem rate
At 3 months post-surgery visit
Hospitalization duration
At 3 months post-surgery visit
Time to complete wound healing
Up to 27 months
Number and types of major wound complications (MWCs)
Up to 27 months
- +3 more secondary outcomes
Study Arms (2)
Arm A : Surgery for STS and prevena
EXPERIMENTALThe 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)
Arm B : Surgery for STS and standard postoperative wound management
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 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 may not qualify if:
- Known hypersensibility to silver
- Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor. Nota bene: Only patients with bone tumors are affected; patients with soft tissue tumors can be included in the study.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
CHU Nantes
Nantes, Pays de Loire, 44093, France
Centre Leon Berard
Lyon, Rhône-Alpes Auvergne, 69008, France
Institut de Cancérologie de l'Ouest - Pays de Loire
Angers, 49055, France
Institut Bergonié
Bordeaux, 33076, France
CHRU Tours Hôpital Trousseau
Chambray-lès-Tours, 37170, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, 21000, France
Centre Oscar Lambert
Lille, 59000, France
CHU Limoges
Limoges, 87042, France
Institut du Cancer de Montpellier
Montpellier, 34090, France
Institut Curie
Paris, 75005, France
APHP Hôpital Cochin
Paris, 75014, France
CHU Rennes
Rennes, 35033, France
IUCT Oncopole
Toulouse, 31100, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Gouin, MD, Chirurgien
Centre Leon Berard
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 13, 2023
Study Start
August 3, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08