Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Device: Prevena
- Registration Number
- NCT05944913
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
- 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.
- Known hypersensibility to silver
- Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor
- Planned no wound-closure and skin graft after resection
- Patient requiring authorship or curators or patient deprived of liberty.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A : Surgery for STS and prevena 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)
- Primary Outcome Measures
Name Time Method The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS At 3 months post-surgery visit Assessed by major wound complications rate
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events 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)
Three months secondary surgery for wound healing problem rate At 3 months post-surgery visit Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months
Quality of life using EQ-5D-5L 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.
Three month deep infection rate At 3 months post-surgery visit Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months
Hospitalization duration At 3 months post-surgery visit Defined as the number of hospitalization days from the date of surgery to the date of discharge
Time to complete wound healing 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)
Number and types of major wound complications (MWCs) Up to 27 months Assessed by a number and differens types of a major wound complications
Quality of life using FACT-G 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.
Trial Locations
- Locations (13)
CHU Nantes
🇫🇷Nantes, Pays De Loire, France
Institut Bergonié
🇫🇷Bordeaux, France
Centre Leon Berard
🇫🇷Lyon, Rhône-Alpes Auvergne, France
CHRU Tours Hôpital Trousseau
🇫🇷Chambray-lès-Tours, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Centre Oscar Lambert
🇫🇷Lille, France
CHU Limoges
🇫🇷Limoges, France
Institut du Cancer de Montpellier
🇫🇷Montpellier, France
Institut Curie
🇫🇷Paris, France
APHP Hôpital Cochin
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
IUCT Oncopole
🇫🇷Toulouse, France