- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02578004
Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
Přehled studie
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Sousse, Tunisko, 4000
- Latifa KHLIFI
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Anthropometric characteristics
Časové okno: one hour
|
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
Časové okno: one hour
|
- 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
Časové okno: one hour
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one hour
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Renal failure
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: one hour
|
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one hour
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Marker of lipid peroxidation
Časové okno: one day
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one day
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Antioxidant parameters
Časové okno: 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
Časové okno: 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
Časové okno: one hour
|
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
Časové okno: 3 hours
|
- 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 1 days
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1 days
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Genotyping of TNF- α G238A
Časové okno: 1 days
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1 days
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Genotyping of TNF- α G308A
Časové okno: 1 days
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1 days
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CHU Farhat Hached
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