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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Junqing Liang, Graduate
- 전화번호: 8832 +8615201091164
- 이메일: yinpin777@126.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100044
- 모병
- Peking University People's Hospital
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부수사관:
- Ying Wang
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연락하다:
- Junqing Liang, Graduate
- 전화번호: +8615201091164
- 이메일: yinpin777@126.com
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부수사관:
- Weilin Zhang
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부수사관:
- Yuxiao Yang
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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exit-site infection
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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catheter-related blood stream infection(CRBSI)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Liangying Gan, Department of Nephrology, Peking University People's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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