Clinical trial · Interventional
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy
NCT05944913CI-TRIAL-00093332TPN-RADrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prevena | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A : Surgery for STS and prevena
- description
- 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)
- interventionNames
- Device: Prevena
- type
- NO_INTERVENTION
- label
- Arm B : Surgery for STS and standard postoperative wound management
- description
- 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.
Primary outcomes (1)
- measure
- The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.