- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01537835
Bacterial Contamination of Healthcare Worker Uniforms
Bacterial Contamination of Healthcare Worker Uniforms: A Study of Antimicrobial Uniforms on Occupationally Acquired Bacterial Contamination: A Randomized Controlled Trial
Healthcare worker uniforms are frequently contaminated with bacteria known to cause infections in humans. These bacteria are acquired during the workday. A new technology of antimicrobial textiles have been developed and incorporated into the fabric of health care worker uniforms, reportedly with effectiveness rates of > 99% but there is little literature describing the effectiveness of Healthcare worker (HCW) uniforms with antimicrobial properties in the clinical setting. Because of the potential benefit that such uniforms could offer HCWs and patients alike, further investigation into whether these fabrics are effective is warranted.
Up to 140 physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards will be invited to participate in this study. Participants will be randomized to wear either uniforms (scrubs) that have antimicrobial properties or standard scrubs provided by the hospital. At the end of an 8-hour workday, three areas on each uniform and each subject's wrist area will be cultured to assess for total bacterial colonization as well as for various resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and resistant gram-negative rods.
Primary Hypothesis: HCW uniforms with antimicrobial properties will have less bacterial contamination than standard uniforms (scrubs) at the end of an 8-hour workday.
Specific aim 1a. Demonstrate that antimicrobial uniforms will have less total bacterial contamination of sites swabbed compared to standard uniform after an 8-hour workday.
Specific aim 1b. Demonstrate that antimicrobial uniforms will have less antimicrobial-resistant bacterial contamination (specifically looking for MRSA, VRE, and resistant gram negatives) of sites swabbed compared to standard uniform after an 8-hour workday.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Colorado
-
Denver, Colorado, 미국, 80204
- Denver Health and Hospital Authority
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Physicians, nurses, and midlevel providers who work at Denver Health on the general internal medicine wards;
- Provider must be available for cultures at the end of the day, provider must be on service at Denver
- Health for the duration of the study, provider must be willing to avoid wearing white coats
Exclusion Criteria:
- Refusal to participate
- Known to be pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Standard Scrubs
Participants will be randomized to one of three types of uniforms.
This arm is the standard scrub arm.
The participants will wear new standard scrubs.
|
|
|
실험적: Antimicrobial Scrubs 1
Participants will be randomized to one of three types of uniforms.
In this arm, the participants will wear one of two types of antimicrobial uniforms.
These are commercially available and registered with the Environmental Protective Agency.
|
Participants will be randomized to one of three types of scrubs.
There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
|
|
실험적: Antimicrobial Scrubs 2
Participants will be randomized to one of three types of uniforms.
In this arm, the participants will wear one of two types of antimicrobial uniforms.
These are commercially available and registered with the Environmental Protective Agency.
|
Participants will be randomized to one of three types of scrubs.
There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.
기간: 8 hours
|
Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.
|
8 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.
기간: 8 hours
|
Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.
|
8 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marisha A Burden, MD, Denver Health and Housing Authority
간행물 및 유용한 링크
일반 간행물
- Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011 Apr;6(4):177-82. doi: 10.1002/jhm.864. Epub 2011 Feb 10.
- Burden M, Keniston A, Frank MG, Brown CA, Zoucha J, Cervantes L, Weed D, Boyle K, Price C, Albert RK. Bacterial contamination of healthcare workers' uniforms: a randomized controlled trial of antimicrobial scrubs. J Hosp Med. 2013 Jul;8(7):380-5. doi: 10.1002/jhm.2051. Epub 2013 Jun 12.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .