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NCT Number: NCT05944913

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nantes, Nantes, Pays de Loire, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevena

Device

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.

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

    Time frame: Within the 3-month postoperative period.

    Assessed by major wound complications rate

Secondary outcomes

  1. Three month deep infection rate

    Time frame: At 3 months post-surgery visit

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

  2. Three months secondary surgery for wound healing problem rate

    Time frame: At 3 months post-surgery visit

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

  3. Hospitalization duration

    Time frame: At 3 months post-surgery visit

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

  4. Time to complete wound healing

    Time frame: Up to 27 months

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

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

    Time frame: Up to 27 months

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

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

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

    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.

  7. Incidence of Adverse Events

    Time frame: Up to 27months

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

  8. Quality of life using FACT-G

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

François Gouin, MD, Chirurgien

CONTACT

[email protected]

0469855311 ext. +33

Séverine METZGER, Project Manager

CONTACT

[email protected]

0478782786 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: TPN-RAD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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