The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
調査の概要
詳細な説明
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Shanghai、中国
- Shanghai Ninth People's Hospital
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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:
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 50 to 800 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Exclusion Criteria:
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Rupture of expanded skin, expander exposure;
- Significant renal, cardiovascular, hepatic and psychiatric diseases;
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- BMI less than 17 or insufficient subcutaneous fat;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- History of allogenic bone marrow transplantation;
- Pregnant or lactating woman;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate
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：4倍
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：Experimental: Fat grafting
Autologous fat graft transplantation subdermally to expanded skin.
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In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline.
Patients will receive autologous fat graft transplantation subdermally to expanded skin.
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介入なし：Control
Expansion was discontinued until the early signs of complication disappeared.
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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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To Measure the Change in Expansion Volume
時間枠：Change from baseline volume at 12 weeks
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Record the volume(ml) of each expander
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Change from baseline volume at 12 weeks
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To Measure the Change in Skin Thickness
時間枠：Change from baseline skin thickness at 12 weeks
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Record the thickness of the expanded skin(cm) by ultrasound scanning
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Change from baseline skin thickness at 12 weeks
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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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To Measure the Texture of Expanded Flap with VISIA scanner
時間枠：baseline and 12 weeks post treatment
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Evaluate skin texture with VISIA scanner and compare the characteristics
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baseline and 12 weeks post treatment
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Occurence of Major Adverse Events
時間枠：Up to approximately 12 weeks after study start
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Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
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Up to approximately 12 weeks after study start
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協力者と研究者
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
- Shanghai9PH
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Fat graftingの臨床試験
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Centre Hospitalier Universitaire de la Réunion完了