- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02578004
Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Sousse, 튀니지, 4000
- Latifa KHLIFI
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- presenting with at least of a wound and confirmed diagnosis of PU, age≥18 years old, bedridden, not feeds only and without trophic and mental disorders.
Exclusion Criteria:
- paediatric study populations, age > 90 years old, allergy to wound products, malignant origin
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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100 patients suffering from pressure ulcer
100 subjects were having at least one wound of pressure ulcer (74 men and 26 women) middle-aged (55.5±20 years) and were recruited from many services of three University Regional hospitals of Tunisia.
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213 healthy subjects
213 healthy subjects (125 men and 88 women) middle-aged (51.5±17 years).
Although, healthy individuals, were included as controls, followed in the outpatient services of the University Hospital Farhat Hached and they considered clinically free of pressure ulcer and tissue necrosis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anthropometric characteristics
기간: one hour
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Body Mass Index (BMI) is a simple index of weight-for-height.
It is defined as the weight in kilograms divided by the square of the height in metres (kg/m2).
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one hour
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Diabetes mellitus
기간: one hour
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- Plasma levels glucose in mmol/l was measured by standard enzymatic methods using reagents in a fully automated analyzer Cx5 Pro-Bechman Coulter-Fuller-Ton
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one hour
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Dyslipidemia
기간: one hour
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one hour
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Renal failure
기간: one hour
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- renal profile: urea (mmol/l), creatinine and uric acid (μmol/l) levels were measured by standard enzymatic methods using reagents in a fully automated analyzer ( Cx9 Pro-Bechman Coulter-Fuller-Ton).
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one hour
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Inflammatory parameter
기간: one hour
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- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
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one hour
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Endogenous inflammatory marker
기간: one hour
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- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
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one hour
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Markers of nutritional status
기간: one hour
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one hour
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Marker of lipid peroxidation
기간: one day
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one day
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Antioxidant parameters
기간: one day
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- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
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one day
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Total antioxidant status
기간: one hour
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Serum total antioxidant status in mmol/l was measured with RANDOX kit (Cat.
No. NZ 2332; Randox Labs Ltd., Crumlin, UK) by colorimetric method at 600 nm .
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one hour
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Determination of trace elements
기간: one hour
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Serum copper in μmol/l was indicated spectrophotometrically with RANDOX kit (Cat. No. CU 2340; Randox Labs Ltd., Crumlin, UK) at 580 nm according. Serum zinc was measured in μmol/l with RANDOX kit (Cat. No. ZN 2341; Randox Labs Ltd, Crumlin, UK) at 560 nm. |
one hour
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Nutritional status
기간: 3 hours
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- Nutritional Risk Index (NRI) was originally derived from the serum albumin concentration and the ratio of present to usual weight [NRI = (1.489
x albumin, g/L) + (41.7 x present weight/ideal body weight)] and categorized as follows: severe risk (NRI < 83.5), moderate risk (83.5 < NRI < 97.5) and no risk (NRI > 97.5).
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3 hours
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Nutritional risk
기간: 3 hours
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- Prognostic Inflammatory and Nutritional Index (PINI) is a simple clinical [PINI = AAG x CRP / albumine x prealbumin] and classificated as follows: normal (1<PINI score <10), mild malnutrition (11<PINI score<20), severe malnutrition (21<PINI score<30) and risk for death when PINI score >30. These scores gained in popularity as it uses an objective rather than subjective measurements to determine nutritional risk in hospitalized patient populations. |
3 hours
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A microbiological diagnosis
기간: 3 days
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The bacterial colonization of a wound is a recognized detrimental factor in the multifactorial process of wound healing. wound per patient suffering from pressure ulcer was cultured by swab to determine the bacterial species of the infection and helps guide antibiotic therapy. The representative sample is collected before topical or systemic antibiotics are initiated and pain assessment should be conducted prior to wound procedures such as dressing changes and debridement. Bacterial swabs provide information on the predominant flora. |
3 days
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Proteomics
기간: 2 days
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- Serum gelatinase activities of MMP-9 by zymography (%)
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2 days
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DNA extraction
기간: 2 days
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Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
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2 days
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Genotype for the MMP9-1562 C/T polymorphism
기간: 1 days
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1 days
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Genotyping of TNF- α G238A
기간: 1 days
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1 days
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Genotyping of TNF- α G308A
기간: 1 days
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1 days
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공동 작업자 및 조사자
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 연구와 관련된 용어
기타 연구 ID 번호
- CHU Farhat Hached
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