Comparing negative pressure dressing to standard dressing for healing after soft tissue sarcoma surgery
Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy
This study is testing if a special type of dressing called negative pressure therapy can help people heal better after surgery for soft tissue sarcoma compared to regular dressings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | radiation |
| Locations | 15 sites (Nantes, Pays de Loire and 14 other locations) |
| Trial ID | NCT05944913 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, controlled trial that aims to evaluate the effectiveness of negative pressure wound therapy (PREVENA™) compared to conventional postoperative wound management in patients who have undergone surgery for soft tissue sarcoma (STS) after receiving preoperative radiation therapy. The research focuses on reducing postoperative complications associated with surgical resection of STS, which can be exacerbated by prior radiation treatment. By comparing these two approaches, the study seeks to determine if negative pressure therapy can improve wound healing outcomes without increasing the risk of local recurrence. Participants will be monitored for wound complications and overall recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary soft tissue sarcoma of the limb or trunk who have received preoperative radiation therapy.
Not a fit: Patients with certain types of sarcomas other than soft tissue sarcoma, or those requiring skin grafts or having hypersensitivity to silver, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing surgery for soft tissue sarcoma.
How similar studies have performed: Previous studies using negative pressure wound therapy have shown promising results in reducing wound complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantes, Pays de Loire and 14 other locations
- CHU Nantes — Nantes, Pays de Loire, France (Recruiting)
- Centre Leon Berard — Lyon, Rhône-Alpes Auvergne, France (Recruiting)
- Institut de Cancérologie de l'Ouest - Pays de Loire — Angers, France (Recruiting)
- Institut Bergonié — Bordeaux, France (Recruiting)
- CHRU Tours Hôpital Trousseau — Chambray-lès-Tours, France (Recruiting)
- Centre Jean Perrin — Clermont-Ferrand, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- Centre Oscar Lambert — Lille, France (Recruiting)
- CHU Limoges — Limoges, France (Recruiting)
- Institut du Cancer de Montpellier — Montpellier, France (Recruiting)
- Institut Curie — Paris, France (Not_yet_recruiting)
- APHP Hôpital Cochin — Paris, France (Not_yet_recruiting)
- CHU Rennes — Rennes, France (Not_yet_recruiting)
- IUCT Oncopole — Toulouse, France (Recruiting)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)
Study contacts
- Principal investigator: François Gouin, MD, Chirurgien — Centre Leon Berard
- Study coordinator: François Gouin, MD, Chirurgien
- Email: Francois.GOUIN@lyon.unicancer.fr
- Phone: 0469855311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.