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

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)

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Device: Prevena

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Gouin, MD, Chirurgien; Phone Number: +33 0469855311; Email: Francois.GOUIN@lyon.unicancer.fr
• Study Contact Backup: Name: Séverine METZGER, Project Manager; Phone Number: +33 0478782786; Email: severine.metzger@lyon.unicancer.fr

Study Locations

• France
  • Angers, France, 49055
    • Recruiting
    • Institut de Cancérologie de l'Ouest - Pays de Loire
    • Contact: WERNERT Romuald, MD; Phone Number: 02 41 35 27 00; Email: romuald.wernert@ico.unicancer.fr
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonié
    • Contact: MICHOT Audrey, MD,surger; Phone Number: 0556333216; Email: a.michot@bordeaux.unicancer.fr
  • Chambray-lès-Tours, France, 37170
    • Recruiting
    • CHRU Tours Hôpital Trousseau
    • Contact: LE NAIL Louis-Romée, MD,surger; Email: lr.lenail@chu-tours.fr
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre Jean Perrin
    • Contact: GIMBERGUES Pierre, MD,surger; Phone Number: 0473278000; Email: pierre.gimbergues@clermont.unicancer.fr
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges François Leclerc
    • Contact: CAUSERET Sylvain, MD, surger; Email: scauseret@cgfl.fr
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambert
    • Contact: DECANTER Gauthier, MD,surger; Email: g-decanter@o-lambret.fr
  • Limoges, France, 87042
    • Recruiting
    • CHU Limoges
    • Contact: FIORENZA Fabrice, MD,surger; Email: fabrice.fiorenza@chu-limoges.fr
  • Montpellier, France, 34090
    • Recruiting
    • Institut du Cancer de Montpellier
    • Contact: CARRERE Sébastien, MD,surger; Phone Number: 0467614539; Email: sebastien.carrere@icm.unicancer.fr
  • Paris, France, 75005
    • Not yet recruiting
    • Institut Curie
    • Contact: TZANIS Dimitri, MD, surger; Email: dimitri.tzanis@curie.fr
  • Paris, France, 75014
    • Not yet recruiting
    • APHP Hôpital Cochin
    • Contact: BIAU David, MD,surger; Email: david.biau@aphp.fr
  • Rennes, France, 35033
    • Not yet recruiting
    • Chu Rennes
    • Contact: ROPARS Mickaël, MD,surger; Email: mickael.ropars@chu-rennes.fr
  • Toulouse, France, 31100
    • Recruiting
    • IUCT Oncopole
    • Contact: MERESSE Thomas, MD,surger; Phone Number: 0531156032; Email: meresse.thomas@iuct-oncopole.fr
  • Vandœuvre-lès-Nancy, France, 54519
    • Not yet recruiting
    • Institut de Cancerologie de Lorraine
    • Contact: MARCHAL Frédéric, MD; Phone Number: 03 83 59 84 51; Email: f.marchal@nancy.unicancer.fr
  • Pays de loire
    • Nantes, Pays de loire, France, 44093
      • Recruiting
      • CHU Nantes
      • Contact: CRENN Vincent, MD,surger; Phone Number: +33 0240083761; Email: vincent.crenn@chu-nantes.fr
  • Rhône-Alpes Auvergne
    • Lyon, Rhône-Alpes Auvergne, France, 69008
      • Recruiting
      • Centre Leon Berard
      • Contact: GOUIN François, MD, surger; Phone Number: +33 0469855311; Email: francois.gouin@lyon.unicancer.fr
      • Contact: VAZ Gualter, MD, Surger; Phone Number: +33 0469855310; Email: gualter.vaz@lyon.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three month deep infection rate	Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months	At 3 months post-surgery visit
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	At 3 months post-surgery visit
Hospitalization duration	Defined as the number of hospitalization days from the date of surgery to the date of discharge	At 3 months post-surgery visit
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)	Up to 27 months
Number and types of major wound complications (MWCs)	Assessed by a number and differens types of a major wound complications	Up to 27 months
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.	At 28 days and 3 months after surgery for each patients
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)	Up to 27months
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.	At 28 days and 3 months after surgery for each patients

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: François Gouin, MD, Chirurgien, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: STS; Negative Pressure Wound Therapy; Surgery with preoperative irradiation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: ET22-146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No