Исследование, сравнивающее повязку с отрицательным давлением и обычную повязку у пациентов с резекцией СТС после лучевой терапии (TPN-RAD)
Рандомизированное исследование, сравнивающее повязку с отрицательным давлением и обычную повязку у пациентов с резецированной саркомой мягких тканей конечности или туловища (СМТ) после дистанционной лучевой терапии
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)
Обзор исследования
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
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Angers, Франция, 49055
- Institut de Cancérologie de l'Ouest - Pays de Loire
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Bordeaux, Франция, 33076
- Institut Bergonié
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Chambray-lès-Tours, Франция, 37170
- CHRU Tours Hôpital Trousseau
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Clermont-Ferrand, Франция, 63011
- Centre Jean Perrin
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Dijon, Франция, 21000
- Centre Georges François Leclerc
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Lille, Франция, 59000
- Centre Oscar Lambert
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Limoges, Франция, 87042
- CHU Limoges
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Montpellier, Франция, 34090
- Institut du Cancer de Montpellier
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Paris, Франция, 75014
- APHP Hôpital Cochin
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Rennes, Франция, 35033
- CHU Rennes
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Toulouse, Франция, 31100
- IUCT Oncopole
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Vandœuvre-lès-Nancy, Франция, 54519
- Institut de Cancérologie de Lorraine
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Pays de Loire
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Nantes, Pays de Loire, Франция, 44093
- CHU Nantes
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Rhône-Alpes Auvergne
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Lyon, Rhône-Alpes Auvergne, Франция, 69008
- Centre Leon Berard
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Без вмешательства: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
Временное ограничение: Within the 3-month postoperative period.
|
Assessed by major wound complications rate |
Within the 3-month postoperative period.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Three month deep infection rate
Временное ограничение: 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
|
|
Three months secondary surgery for wound healing problem rate
Временное ограничение: 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
|
|
Hospitalization duration
Временное ограничение: At 3 months post-surgery visit
|
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
Временное ограничение: 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)
Временное ограничение: Up to 27 months
|
Assessed by a number and differens types of a major wound complications |
Up to 27 months
|
|
Quality of life using EQ-5D-5L
Временное ограничение: 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
|
|
Incidence of Adverse Events
Временное ограничение: 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) |
Up to 27months
|
|
Quality of life using FACT-G
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: François Gouin, MD, Chirurgien, Centre Leon Berard
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ET22-146
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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