放疗后切除 STS 患者的负压敷料与传统敷料比较的研究 (TPN-RAD)
外部放射治疗后肢体或躯干软组织肉瘤 (STS) 切除患者比较负压敷料与传统敷料的随机研究
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)
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Angers、法国、49055
- Institut de Cancérologie de l'Ouest - Pays de Loire
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Bordeaux、法国、33076
- Institut Bergonié
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Chambray-lès-Tours、法国、37170
- CHRU Tours Hôpital Trousseau
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Clermont-Ferrand、法国、63011
- Centre Jean Perrin
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Dijon、法国、21000
- Centre Georges François Leclerc
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Lille、法国、59000
- Centre Oscar Lambert
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Limoges、法国、87042
- CHU Limoges
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Montpellier、法国、34090
- Institut du Cancer de Montpellier
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Paris、法国、75014
- APHP Hôpital Cochin
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Rennes、法国、35033
- CHU Rennes
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Toulouse、法国、31100
- IUCT Oncopole
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Vandœuvre-lès-Nancy、法国、54519
- Institut de Cancérologie de Lorraine
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Pays de Loire
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Nantes、Pays de Loire、法国、44093
- CHU Nantes
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Rhône-Alpes Auvergne
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Lyon、Rhône-Alpes Auvergne、法国、69008
- Centre Leon Berard
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
大体时间：Within the 3-month postoperative period.
|
Assessed by major wound complications rate |
Within the 3-month postoperative period.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Three month deep infection rate
大体时间：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
大体时间：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
大体时间：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
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Time to complete wound healing
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
|
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Quality of life using FACT-G
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：François Gouin, MD, Chirurgien、Centre Leon Berard
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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