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Soft Tissue SarcomaTPN-RADNCT05944913

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

A study testing Prevena in people with Soft Tissue Sarcoma, run by Centre Leon Berard at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Prevena
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
15 sitesFrance
Study dates
3 Aug 2023to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François Gouin, MD, Chirurgien contact

0469855311 ext. +33

Francois.GOUIN@lyon.unicancer.fr

Séverine METZGER, Project Manager contact

0478782786 ext. +33

severine.metzger@lyon.unicancer.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • Institut de Cancérologie de l'Ouest - Pays de Loire

    Angers, 49055

    WERNERT Romuald, MD, 02 41 35 27 00, romuald.wernert@ico.unicancer.fr

    Recruiting

  • Institut Bergonié

    Bordeaux, 33076

    MICHOT Audrey, MD,surger, 0556333216, a.michot@bordeaux.unicancer.fr

    Recruiting

  • CHRU Tours Hôpital Trousseau

    Chambray-lès-Tours, 37170

    LE NAIL Louis-Romée, MD,surger, lr.lenail@chu-tours.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    GIMBERGUES Pierre, MD,surger, 0473278000, pierre.gimbergues@clermont.unicancer.fr

    Recruiting

  • Centre Georges François Leclerc

    Dijon, 21000

    CAUSERET Sylvain, MD, surger, scauseret@cgfl.fr

    Recruiting

  • Centre Oscar Lambert

    Lille, 59000

    DECANTER Gauthier, MD,surger, g-decanter@o-lambret.fr

    Recruiting

  • CHU Limoges

    Limoges, 87042

    FIORENZA Fabrice, MD,surger, fabrice.fiorenza@chu-limoges.fr

    Recruiting

  • Centre Leon Berard

    Lyon, Rhône-Alpes Auvergne, 69008

    GOUIN François, MD, surger, 0469855311 ext. +33, francois.gouin@lyon.unicancer.fr

    VAZ Gualter, MD, Surger, 0469855310 ext. +33, gualter.vaz@lyon.unicancer.fr

    Recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34090

    CARRERE Sébastien, MD,surger, 0467614539, sebastien.carrere@icm.unicancer.fr

    Recruiting

  • CHU Nantes

    Nantes, Pays de Loire, 44093

    CRENN Vincent, MD,surger, 0240083761 ext. +33, vincent.crenn@chu-nantes.fr

    Recruiting

  • Institut Curie

    Paris, 75005

    TZANIS Dimitri, MD, surger, dimitri.tzanis@curie.fr

    Not yet recruiting

  • APHP Hôpital Cochin

    Paris, 75014

    BIAU David, MD,surger, david.biau@aphp.fr

    Not yet recruiting

  • CHU Rennes

    Rennes, 35033

    ROPARS Mickaël, MD,surger, mickael.ropars@chu-rennes.fr

    Not yet recruiting

  • IUCT Oncopole

    Toulouse, 31100

    MERESSE Thomas, MD,surger, 0531156032, meresse.thomas@iuct-oncopole.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    MARCHAL Frédéric, MD, 03 83 59 84 51, f.marchal@nancy.unicancer.fr

    Not yet recruiting

Other trials in France

About this study

Official title: Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy

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)

Read the detailed description

The gold standard treatment for primary non-metastatic STS is complete surgical resection. Peri-operative Radiation Therapy (RT) has been proved to improve local control . Nevertheless, the timing of RT, whether preoperative or postoperative, remains a debate.

Both have similar local control efficacy, but preoperative RT results in lower rates of long-term fibrosis and lymphedema and improved joint mobility than postoperative RT. On the other hand, the adverse effect of pre-operative RT is a higher rate of wound post-operative complications and re-operations.

Any effort to reduce the high rate of postoperative complications could offer the advantage of preoperative RT in terms of reduced long-term sequelae compared with postoperative RT without a higher wound complication rate postoperatively. Short retrospective series of Negative Pressure Wound Therapy (NPWT) after surgical resection of Soft Tissue Sarcoma (STS) have reported very encouraging results in preventing wound complications: patients treated with NPWT were less likely to develop wound complications than those who did not receive it. Both groups did not report an increased rate of local recurrence. The use of NPWT would also reduce the cost of care by avoiding complications.

That's why the investigators propose this study comparing the use of a negative pressure dressing to a conventional dressing in patients with STS of the limbs or trunk resected after neo-adjuvant external radiotherapy.

Being tested
Prevena
Keywords
STS, Negative Pressure Wound Therapy, Surgery with preoperative irradiation
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrevenaDevice

    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 groups in NCT05944913
Study groupRoleWhat they receive
Arm A : Surgery for STS and prevenaExperimentalThe 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)
Receives: Device: Prevena
Arm B : Surgery for STS and standard postoperative wound managementNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within the 3-month postoperative period.

Secondary outcomes (8)

  1. Three month deep infection rate

    Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months

    Measured: At 3 months post-surgery visit

  2. Three months secondary surgery for wound healing problem rate

    Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months

    Measured: At 3 months post-surgery visit

  3. Hospitalization duration

    Defined as the number of hospitalization days from the date of surgery to the date of discharge

    Measured: At 3 months post-surgery visit

  4. Time to complete wound healing

    Defined as the interval from surgery to 100% healing (total wound closure with no need for dressing and any local care)

    Measured: Up to 27 months

  5. Number and types of major wound complications (MWCs)

    Assessed by a number and differens types of a major wound complications

    Measured: Up to 27 months

  6. Quality of life using EQ-5D-5L

    Assessed by EQ-5D-5L introduce by EuroQol Group in 2009 with five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. A minimum value is 0 and a maximum value is 100. A mean worst value is 0 and a better mean value is 100.

    Measured: At 28 days and 3 months after surgery for each patients

  7. Incidence of Adverse Events

    Defined by the number of patients with Adverse Events (any type and any grade using the NCI-CTC AE scale version 5.0)

    Measured: Up to 27months

  8. Quality of life using FACT-G

    Assessed by FACT-G : Functionnal Assesment of Cancer Therapy with 27 items. There are four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. A minimum value is 0 and a maximum value is 4. A mean worst value is 0 and a better mean value is 108.

    Measured: At 28 days and 3 months after surgery for each patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start3 Aug 2023
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The randomization (1:1 ratio) will be stratified according to STS location (upper limb vs lower limb vs trunk) and ASA class (1 or 2 vs ≥ 3).
Masking
None (open label)
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944913
Sponsor's protocol ID
ET22-146
Acronym
TPN-RAD
Status last verified
Aug 2025
First submitted
26 Jun 2023
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Prevena in people with Soft Tissue Sarcoma, run by Centre Leon Berard at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François Gouin, MD, Chirurgien (0469855311 ext. +33, Francois.GOUIN@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05944913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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