Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter
Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
調査の概要
詳細な説明
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Junqing Liang, Graduate
- 電話番号：8832 +8615201091164
- メール：yinpin777@126.com
研究場所
-
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Beijing
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Beijing、Beijing、中国、100044
- 募集
- Peking University People's Hospital
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副調査官：
- Ying Wang
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コンタクト：
- Junqing Liang, Graduate
- 電話番号：+8615201091164
- メール：yinpin777@126.com
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副調査官：
- Weilin Zhang
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副調査官：
- Yuxiao Yang
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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:
- age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.
Exclusion Criteria:
- current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Semi-permeable film dressing
Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.
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Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
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|
他の：sterile gauze and tape dressing
Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
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Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.
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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 |
|---|---|---|
|
exit-site infection
時間枠：before disinfectant and dressing change at every hemodialysis session within 2 weeks
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redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin
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before disinfectant and dressing change at every hemodialysis session within 2 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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catheter-related blood stream infection(CRBSI)
時間枠：within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
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At least one blood culture from peripheral venous puncture was collected at CVC removal and whenever a catheter-related infection or other type of sepsis was suspected (temperature 38.2°C or 36.5°C or chills, leukocytes 10,000 or 4,000, or other signs of sepsis according the diagnosis of CDC
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within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
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skin erythema and dryness under the dressing area
時間枠：before disinfectant and dressing change at every hemodialysis session within 2 weeks
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The following scale was used for erythema [modified from Fitzpatrick et al. (20)]: 0 ¼ none; 0.5 ¼ equivocal erythema; 1 ¼ slight redness, spotty and diffuse; 2 ¼ moderate uniform redness; 3 ¼ intense redness; 4 ¼ fiery red with oedema.The following scale was used for dryness:0 ¼ none; 1 ¼ slight scaling, dryness; 2 ¼ moderate scaling, dryness; 3 ¼ severe dryness with large flakes.
The sum score of dryness and erythema over all assessment times served as outcome parameter.
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before disinfectant and dressing change at every hemodialysis session within 2 weeks
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total bacterial count
時間枠：Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session)
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cotton swab in skin within 2 cm around the exit-site of CVC under the dressing
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Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session)
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dressing intactness
時間枠：before disinfectant and dressing change at every hemodialysis session within 2 weeks
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if all the corners or edges of dressing is intact, count how many corners or edges rolled up or fell off
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before disinfectant and dressing change at every hemodialysis session within 2 weeks
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nursing time for dressing change
時間枠：at any of the session, once only
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how much time a dressing change procedure cost in minutes.
Nursing time are recorded by other nurse using a clock while the nurse change dressing for a patient.the
whole time cost of the nurse doing dressing change should be the outcome.
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at any of the session, once only
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協力者と研究者
捜査官
- スタディディレクター：Liangying Gan、Department of Nephrology, Peking University People's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
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
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
本研究に関する用語
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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