- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03813693
The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation
Surgical Site Infection and the Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation: a Pilot Randomized Clinical Trial.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Parana
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Curitiba, Parana, 브라질
- Fernanda de Oliveira Andrade
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age or over
- literate
- undergoing potentially contaminated elective surgeries
- admitted on the day before the surgical treatment or in the triple three-day hospital stay prior to surgery, without an infectious or otherwise infected process
- correctly follow the instructions for the use of towels impregnated with chlorhexidine gluconate 2%
- follow the instructions for the use of chlorhexidine gluconate 2%
Exclusion Criteria:
- submitted to previous surgeries, in a period of less than thirty days, or ninety days in the case of a prosthesis implant
- present skin lesions or known allergy to chlorhexidine gluconate 2%
- patients submitted to videolaparoscopic surgeries and vaginal surgeries
- patients who had daily use of products containing antiseptics (creams and / or liquid or bar soaps containing CHG, triclosan or similar) in their daily activity; or who had used antibiotics or similar drugs two weeks before and during the period of data collection.
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: towels with chlorhexidine gluconate 2%
Composed of 25 patients, who received 2 towels with chlorhexidine gluconate 2% packages each containing six towels and detailed instructions on the form and sequence of application of the towels; the time of application, that is, the night before surgery, between 20 and 22h, and, on the morning of surgery, between 5 and 6h; besides other general orientations.
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The first TICHG should be used on the neck, chest and abdomen; The second TICHG should be used on the right upper limb, start at the shoulder; The third TICHG was intended for the upper left limb; The fourth TICHG should be used on the neck and chest; The fifth TICHG was for the right lower limb; The sixth TICHG should be used on the lower left limb. 2) Time of application: use six TICHGs the night before surgery and the six remaining on the morning of surgery. 3) After the hygiene of each member, discard the TICHG. After use of TICHG, allow the product to dry on the skin. Do not use bath towels to dry yourself and wear clean clothes. |
활성 비교기: chlorhexidine gluconate 2% liquid
Composed of 23 patients, two 100 ml flasks of chlorhexidine gluconate 2% liquid were supplied, and detailed instruction manual for the product, containing form and application sequence; time of application (the night before surgery, between 20 and 22h, and on the morning of surgery, between 5 and 6h); and general guidelines.
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Spread the product on the skin during the bath and massage for 3 minutes, so that it is distributed equally to all parts of the body (except the face, hair and intimate area).
Then rinse with water and dry with a clean, dry towel, and wear clean clothes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018
기간: 1 month (30 days)
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In order to investigate the potential cases of SSI, the researcher personally followed the patients in the preoperative period, in the POI and at the time of hospital discharge, using a data collection instrument. In order to evaluate the occurrence of SSI after hospital discharge, the researcher used the following strategies: a review of the chart associated with patient follow-up during outpatient return when possible, which would occur on average on the 35th postoperative day; telephone contact from the 30th day until the 40th postoperative day (PO), using a post-discharge surveillance instrument. Continuous and discrete quantitative variables were evaluated using the Wilcoxon-Mann-Whitney test. Qualitative (categorical) variables were evaluated using the Pearson X² test. The Wilcoxon-Mann-Whitney test was used for qualitative (categorical) variables, whose distribution was different from normal. |
1 month (30 days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fernanda Andrade, University of Sao Paulo
- 수석 연구원: Vanessa Poveda, University of Sao Paulo
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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. .
수술 부위 감염에 대한 임상 시험
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Cairo University알려지지 않은Computer Guided Implantology에서 Surgical Guide의 정확성이집트
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EarlySense Ltd.빼는
towels impregnated with 2% chlorhexidine gluconate에 대한 임상 시험
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Jared BrooksNorthwestern Medicine완전한
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Istanbul University - Cerrahpasa (IUC)완전한피부 병변 | 카테터 관련 감염 | 간호우식증 | 어린이, 전용 | 카테터 | 소독 염료 부작용 | 클로르헥시딘 부작용칠면조
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Johns Hopkins UniversityRobert Wood Johnson Foundation완전한