Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
Primary Objective:
1. To determine whether the use of a fibrin sealant applied to superficial groin soft tissues following node dissection can result in decreased cumulative postoperative drainage, earlier drain removal, and lower incidence of seroma.
Secondary Objectives:
- To determine the postoperative morbidity rate using fibrin sealant following superficial groin dissection.
- To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
- To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.
調査の概要
詳細な説明
Patients in this study are scheduled to have groin dissection as part of their surgery for treatment of their melanoma.
Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history.
These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected groin area. Patients in the other group will receive no fibrin sealant.
For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed.
The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal.
Follow-up wound exams will be performed by the local primary physician or in the M.D. Anderson Melanoma Clinic between 1-4 weeks and 6 weeks after surgery. Participation will be over after the 6-week follow-up.
This is an investigational study. The sealant is FDA approved, though its use in this study is experimental. About 58 patients will take part in this study. All will be enrolled at M. D. Anderson.
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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Texas
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Houston、Texas、アメリカ、77030
- U.T.M.D. Anderson Cancer Center
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Part I - Inclusion Criteria Patients that consent to participate.
- Patients with melanoma who have undergone superficial node dissection (with or without a concurrent deep (ilioinguinal) node dissection within the last six months as part of their surgical treatment will be considered for the study.
- Part II- Inclusion Criteria Patients that consent to participate.
- Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.
Exclusion Criteria:
- Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins.
- Patient has undergone prior radiation therapy to the operative site (groin).
- Patient is pregnant or lactating.
- Patient is steroid dependent within last 6 months.
- Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
- Patients with pre-existing lymphedema.
- Patients with other pre-existing medical conditions as per the discretion of the principal investigator.
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：処理
- 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 |
|---|---|
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介入なし：フィブリンシーラントなし
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実験的：Fibrin Sealant
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Tisseel applied externally to the dissected groin area.
他の名前：
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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 |
|---|---|---|
|
Time-to-Drain Removal
時間枠：From surgery to 30 days post surgery
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The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or < 30 days has elapsed since surgery.
Time calculated as days from installation of drain at first day of surgery to removal.
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From surgery to 30 days post surgery
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協力者と研究者
協力者
捜査官
- 主任研究者：Janice N. Cormier, MD、M.D. Anderson Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- GS01-564
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