Studie srovnávající převazy s negativním tlakem vs. konvenční u pacientů s resekovaným STS po radioterapii (TPN-RAD)
Randomizovaná studie srovnávající převazy s negativním tlakem versus konvenční převaz u pacientů s resekovaným sarkomem měkkých tkání končetiny nebo trupu (STS) po externí radioterapii
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)
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Angers, Francie, 49055
- Institut de Cancérologie de l'Ouest - Pays de Loire
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Bordeaux, Francie, 33076
- Institut Bergonié
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Chambray-lès-Tours, Francie, 37170
- CHRU Tours Hôpital Trousseau
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Clermont-Ferrand, Francie, 63011
- Centre Jean Perrin
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Dijon, Francie, 21000
- Centre Georges François Leclerc
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Lille, Francie, 59000
- Centre Oscar Lambert
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Limoges, Francie, 87042
- CHU Limoges
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Montpellier, Francie, 34090
- Institut du Cancer de Montpellier
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Paris, Francie, 75014
- APHP Hôpital Cochin
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Rennes, Francie, 35033
- CHU Rennes
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Toulouse, Francie, 31100
- IUCT Oncopole
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Vandœuvre-lès-Nancy, Francie, 54519
- Institut de Cancérologie de Lorraine
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Pays de Loire
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Nantes, Pays de Loire, Francie, 44093
- CHU Nantes
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Rhône-Alpes Auvergne
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Lyon, Rhône-Alpes Auvergne, Francie, 69008
- Centre Leon Berard
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm A : Surgery for STS and 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) |
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. |
|
Žádný zásah: Arm B : Surgery for STS and standard postoperative wound management
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
Časové okno: Within the 3-month postoperative period.
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Assessed by major wound complications rate |
Within the 3-month postoperative period.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Three month deep infection rate
Časové okno: At 3 months post-surgery visit
|
Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months |
At 3 months post-surgery visit
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Three months secondary surgery for wound healing problem rate
Časové okno: At 3 months post-surgery visit
|
Assessed by the proportion of patients experiencing a second surgery for wound healing problem within 3 postoperative months |
At 3 months post-surgery visit
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Hospitalization duration
Časové okno: At 3 months post-surgery visit
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Defined as the number of hospitalization days from the date of surgery to the date of discharge |
At 3 months post-surgery visit
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Time to complete wound healing
Časové okno: 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) |
Up to 27 months
|
|
Number and types of major wound complications (MWCs)
Časové okno: Up to 27 months
|
Assessed by a number and differens types of a major wound complications |
Up to 27 months
|
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Quality of life using EQ-5D-5L
Časové okno: 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. |
At 28 days and 3 months after surgery for each patients
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Incidence of Adverse Events
Časové okno: Up to 27months
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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
|
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Quality of life using FACT-G
Časové okno: 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. |
At 28 days and 3 months after surgery for each patients
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: François Gouin, MD, Chirurgien, Centre Leon Berard
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ET22-146
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