Effect of Standard Normothermia Protocol On Surgical Site Infections
Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Elective
- Preoperatively not infected/dirty Surgical Site
- Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
Exclusion Criteria:
- Emergent surgery
- Local/locoregional procedures
- Laparoscopic operation
- Minor abdominal operations (e.g. hernia repair, colostomy closure)
- Malign hyperthermia
- Signs of active infection or fever
- Immunosuppression
- Severe malnutrition
- Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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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介入なし:Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
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アクティブコンパレータ:Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
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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 |
---|---|---|
Surgical Site Infection Rate
時間枠:Postoperative 30 days
|
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square ) |
Postoperative 30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Maintaining Normothermia Rate
時間枠:Surgery day
|
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia) |
Surgery day
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Mustafa Cem Terzi, Proffessor Doctor、Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
出版物と役立つリンク
一般刊行物
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