Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections
調査の概要
詳細な説明
Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery.
Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.
研究の種類
連絡先と場所
研究場所
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
- informed, written consent.
Exclusion Criteria:
- Patients <18 years of age.
- Patients scheduled to undergo procedures outside of the surgical service lines listed above.
- Patients not requiring general or regional anesthesia.
- Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
- Patients who have not provided informed, written consent.
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 |
|---|---|
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First patient in the case pair
This patient will receive the treatment bundle.
S. aureus transmission surveillance will be conducted.
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Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.
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Second patient in the case pair
This patient will receive usual care.
S. aureus transmission surveillance will be conducted.
|
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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Time course in S. aureus transmission decline with the intervention.
時間枠:Up to 52 weeks
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S. aureus transmission events by time.
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Up to 52 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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Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.
時間枠:Up to 52 weeks
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The outcome is the proportional reduction in the necessary sample size of pairs of cases achieved by systematic selection of sample cases as compared with random selection.
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Up to 52 weeks
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協力者と研究者
出版物と役立つリンク
一般刊行物
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- Anderson DJ, Chen LF, Weber DJ, Moehring RW, Lewis SS, Triplett PF, Blocker M, Becherer P, Schwab JC, Knelson LP, Lokhnygina Y, Rutala WA, Kanamori H, Gergen MF, Sexton DJ; CDC Prevention Epicenters Program. Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study. Lancet. 2017 Feb 25;389(10071):805-814. doi: 10.1016/S0140-6736(16)31588-4. Epub 2017 Jan 17.
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一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
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最初の投稿 (実際)
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最終確認日
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本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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