放射線治療後に切除されたSTS患者における陰圧包帯と従来の包帯を比較した研究 (TPN-RAD)
外部放射線療法後に切除された四肢または体幹軟部組織肉腫（STS）患者における陰圧包帯と従来の包帯を比較するランダム化研究
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)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Angers、フランス、49055
- Institut de Cancérologie de l'Ouest - Pays de Loire
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Bordeaux、フランス、33076
- Institut Bergonié
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Chambray-lès-Tours、フランス、37170
- CHRU Tours Hôpital Trousseau
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Clermont-Ferrand、フランス、63011
- Centre Jean Perrin
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Dijon、フランス、21000
- Centre Georges François Leclerc
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Lille、フランス、59000
- Centre Oscar Lambert
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Limoges、フランス、87042
- CHU Limoges
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Montpellier、フランス、34090
- Institut du Cancer de Montpellier
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Paris、フランス、75014
- APHP Hôpital Cochin
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Rennes、フランス、35033
- CHU Rennes
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Toulouse、フランス、31100
- IUCT Oncopole
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Vandœuvre-lès-Nancy、フランス、54519
- Institut de Cancérologie de Lorraine
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Pays de Loire
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Nantes、Pays de Loire、フランス、44093
- CHU Nantes
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Rhône-Alpes Auvergne
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Lyon、Rhône-Alpes Auvergne、フランス、69008
- Centre Leon Berard
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
時間枠：Within the 3-month postoperative period.
|
Assessed by major wound complications rate |
Within the 3-month postoperative period.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Three month deep infection rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：François Gouin, MD, Chirurgien、Centre Leon Berard
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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