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

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

Overview

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)

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.

Interventions

• 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.

Primary outcome measures

• 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.]

Secondary outcome measures (8)

• Three month deep infection rate [Time frame: At 3 months post-surgery visit]
• Three months secondary surgery for wound healing problem rate [Time frame: At 3 months post-surgery visit]
• Hospitalization duration [Time frame: At 3 months post-surgery visit]
• Time to complete wound healing [Time frame: Up to 27 months]
• Number and types of major wound complications (MWCs) [Time frame: Up to 27 months]
• Quality of life using EQ-5D-5L [Time frame: At 28 days and 3 months after surgery for each patients]
• Incidence of Adverse Events [Time frame: Up to 27months]
• Quality of life using FACT-G [Time frame: At 28 days and 3 months after surgery for each patients]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 15 centers

• CHU Nantes — Nantes
• Centre Leon Berard — Lyon
• Institut de Cancérologie de l'Ouest - Pays de Loire — Angers
• Institut Bergonié — Bordeaux
• CHRU Tours Hôpital Trousseau — Chambray-lès-Tours
• Centre Jean Perrin — Clermont-Ferrand
• Centre Georges François Leclerc — Dijon
• Centre Oscar Lambert — Lille
• … and 7 more centers

Identifiers

NCT: NCT05944913 · ET22-146

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗