- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02578004
Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Sousse, Túnez, 4000
- Latifa KHLIFI
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anthropometric characteristics
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: one hour
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|
one hour
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Renal failure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: one hour
|
|
one hour
|
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Marker of lipid peroxidation
Periodo de tiempo: one day
|
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one day
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Antioxidant parameters
Periodo de tiempo: one day
|
- 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 days
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1 days
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Genotyping of TNF- α G238A
Periodo de tiempo: 1 days
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1 days
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Genotyping of TNF- α G308A
Periodo de tiempo: 1 days
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1 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHU Farhat Hached
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