Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Pilot Study: Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery for Mastectomy Breast Flap Creation With Immediate Breast Reconstruction
調査の概要
詳細な説明
This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.
Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.
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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Maryland
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Baltimore、Maryland、アメリカ、21224
- Bayview Medical Center
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital Outpatient Center
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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:
- Women aged 18-75 years.
- Choose bilateral mastectomy followed by immediate breast reconstruction.
- Have no inflammatory breast cancers.
- Have not had radiotherapy before mastectomy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
Exclusion Criteria:
- Active connective tissue disease.
- History of, or plan to undergo irradiation of the breasts.
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：デバイスの実現可能性
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Breast flap creation with PlasmaBlade
During participant's scheduled bilateral mastectomy, breast flap on one breast will be created using low thermal dissection device (PlasmaBlade) on one breast and standard Bovie cautery in the contralateral breast.
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PlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices.
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介入なし：Breast flap creation with Bovie Cautery
During participant's scheduled bilateral mastectomy, breast flap will be created using standard Bovie cautery on the breast contralateral to the one that was created using PlasmaBlade.
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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 |
|---|---|---|
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Perfusion
時間枠：Day of Surgery
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Plastic surgeon objectively assesses degree of perfusion with the SPY Perfusion Assessment system (intra-operative fluorescence imaging system).
Plastic surgeon describes perfusion as Left better than Right, Right better than Left, or both sides equally perfused.
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Day of Surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Drainage
時間枠：Up to 14 days post-operatively.
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Patient records amount of drainage (in cc's) from each drain until drain is removed by plastic surgeon.
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Up to 14 days post-operatively.
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Pain Scores
時間枠：Days 1,2,3,7,30 Post-operatively
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Patient records pains scores using Visual Analog Scale (10cm long line upon which patients indicates level of pain)for each side at Day 1, 2, 3, 7, and 30.
Scores range from 0-10.
Score of 0 corresponds with 0 cm on the line and 10 corresponds with 10cm on the line.
0 indicates no pain and 10 indicates most severe pain.
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Days 1,2,3,7,30 Post-operatively
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協力者と研究者
協力者
捜査官
- 主任研究者：Mehran Habibi, MD、Johns Hopkins Medicine Department of Surgery
- 主任研究者：Gedge D Rosson, MD、Johns Hopkins Medicine Department of Plastic, Reconstructive & Maxillofacial Surgery
出版物と役立つリンク
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
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