Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
調査の概要
詳細な説明
Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and late reconstructions. The complications rates reported in the literature are around 30% for delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site infection rate is approximately 7% and seroma formation rate is approximately 1.2%.
In many of the procedures closed suction drains are left for fluid drainage, in order to reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in this study is to describe the relation between the placement of closed suction drains, the timing for their removal, and immediate post operative complications.
Patients that underwent breast reconstruction with silicone prosthesis and in which drains will be left in the surgical field would be randomly assigned into two groups: a control group, in which drains will be removed when the daily discharge will be below 20 cc for two consecutive days and the study group, in which drains will be removed on post operative day (POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications such as infection, seroma, hematoma and skin necrosis was record and analyzed.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Eyal Winkler, MD
- 電話番号:972-3-5302416
研究連絡先のバックアップ
- 名前:Hadar Israeli, MD
- 電話番号:972-3-530-2416
- メール:Israelihmd@gmail.com
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- patients that underwent immediate or late breast reconstruction with silicone prosthesis (expanders/implants)and in which closed suction drains were left in the operating field according to the decision of the operating surgeon.
- signature of informed consent form
Exclusion Criteria:
- age under 18
- breast reconstruction without prosthesis
- Breast reconstruction without the use of drains
- Active infection during time of surgery in surgical site
- Coagulation disease
- Psychiatric illness
- Immune disease
- Lack of communication or language problems
- Foreign residents, not Israeli citizens
- Prisoners
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
control
drains would be removed when daily discharge will be below 20 cc for 2 consecutive days
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
|
study
drains will be removed on post operative day (POD) 10
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
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
- SHEBA -08-5530 -EW- CTIL
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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