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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Surgery for STS and prevena | Experimental | 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) |
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| Arm B : Surgery for STS and standard postoperative wound management | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS | Assessed by major wound complications rate | Within the 3-month postoperative period. |
| Measure | Description | Time Frame |
|---|---|---|
| Three month deep infection rate | Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months | At 3 months post-surgery visit |
| Three months secondary surgery for wound healing problem rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Gouin, MD, Chirurgien | Contact | 0469855311 | +33 | Francois.GOUIN@lyon.unicancer.fr |
| Séverine METZGER, Project Manager | Contact | 0478782786 | +33 | severine.metzger@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Gouin, MD, Chirurgien | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Recruiting | Nantes | Pays de Loire | 44093 | France |
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The randomization (1:1 ratio) will be stratified according to STS location (upper limb vs lower limb vs trunk) and ASA class (1 or 2 vs ≥ 3).
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Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months |
| At 3 months post-surgery visit |
| Hospitalization duration | Defined as the number of hospitalization days from the date of surgery to the date of discharge | At 3 months post-surgery visit |
| Time to complete wound healing | Defined as the interval from surgery to 100% healing (total wound closure with no need for dressing and any local care) | Up to 27 months |
| Number and types of major wound complications (MWCs) | Assessed by a number and differens types of a major wound complications | Up to 27 months |
| Quality of life using EQ-5D-5L | 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. | At 28 days and 3 months after surgery for each patients |
| Incidence of Adverse Events | Defined by the number of patients with Adverse Events (any type and any grade using the NCI-CTC AE scale version 5.0) | Up to 27months |
| Quality of life using FACT-G | 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. | At 28 days and 3 months after surgery for each patients |
| Centre Leon Berard | Recruiting | Lyon | Rhône-Alpes Auvergne | 69008 | France |
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| Institut de Cancérologie de l'Ouest - Pays de Loire | Recruiting | Angers | 49055 | France |
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| Institut Bergonié | Recruiting | Bordeaux | 33076 | France |
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| CHRU Tours Hôpital Trousseau | Recruiting | Chambray-lès-Tours | 37170 | France |
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| Centre Jean Perrin | Recruiting | Clermont-Ferrand | 63011 | France |
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| Centre Georges François Leclerc | Recruiting | Dijon | 21000 | France |
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| Centre Oscar Lambert | Recruiting | Lille | 59000 | France |
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| CHU Limoges | Recruiting | Limoges | 87042 | France |
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| Institut du Cancer de Montpellier | Recruiting | Montpellier | 34090 | France |
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| Institut Curie | Not yet recruiting | Paris | 75005 | France |
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| APHP Hôpital Cochin | Not yet recruiting | Paris | 75014 | France |
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| CHU Rennes | Not yet recruiting | Rennes | 35033 | France |
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| IUCT Oncopole | Recruiting | Toulouse | 31100 | France |
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| Institut de Cancérologie de Lorraine | Not yet recruiting | Vandœuvre-lès-Nancy | 54519 | France |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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