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Risk Factors for Pressure Ulcers

14 de octubre de 2015 actualizado por: latifa, Centre Hôpital Universitaire Farhat Hached

Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients

Development of pressure ulcer (PU) is complex and multifactorial. The association of a constituted PU and of clinical / biological major elements is demonstrated and justifies. Prevention of PU is an important health priority, one that requires clear identification of risk factors.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

313

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Sousse, Túnez, 4000
        • Latifa KHLIFI

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

19 años a 88 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

This prospective study consisted of 100 patients were having at least one wound of pressure ulcer that met the following inclusion criteria. Who followed in many departments (emergency, orthopedic, physical medicine) of three University Regional hospitals of Tunisia (Farhat Hached and Sahloul Sousse, Fattouma Bourguiba Monastir) were evaluated prospectively.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Control de caso
  • Perspectivas temporales: Retrospectivo

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anthropometric characteristics
Periodo de tiempo: 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).
one hour
Diabetes mellitus
Periodo de tiempo: 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
one hour
Dyslipidemia
Periodo de tiempo: one hour
  • Lipid markers: total serum cholesterol (CH), serum triglyceride, serum HDL- CH, in mmol/l, levels were measured by standard enzymatic methods using reagents in a fully automated analyzer (Randox Antrim, UK; CX9-BECKMANN).
  • Low density lipoprotein cholesterol (LDL-C) in mmol / l was determined by Friedewald formula.
  • non esterified fatty acids in serum was determined by colorimetric method at 550 nm (mmol/l)
one hour
Renal failure
Periodo de tiempo: one hour
- 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).
one hour
Inflammatory parameter
Periodo de tiempo: one hour
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
one hour
Endogenous inflammatory marker
Periodo de tiempo: one hour
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
one hour
Markers of nutritional status
Periodo de tiempo: one hour
  • albumin (chronic marker) and prealbumin (early marker) were measured, in g/l, using the dry chemistry method (BN prospec, siemens).
  • Protide in g/l was measured by standard enzymatic methods using reagents in a fully automated analyzer (CX9-BECKMANN).
one hour
Marker of lipid peroxidation
Periodo de tiempo: one day
  • Serum total homocysteine concentrations in μmol/l were measured by using an AxSYM (ABBOTT) homocysteine assay.
  • thiobarbituric acid reactive substances (TBARS) in serum was determined by the fluorimetric method of Yagi in μmol/l.
one day
Antioxidant parameters
Periodo de tiempo: one day
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
one day
Total antioxidant status
Periodo de tiempo: one hour
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 .
one hour
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
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).
3 hours
Nutritional risk
Periodo de tiempo: 3 hours

- 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
A microbiological diagnosis
Periodo de tiempo: 3 days

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
Proteomics
Periodo de tiempo: 2 days
- Serum gelatinase activities of MMP-9 by zymography (%)
2 days
DNA extraction
Periodo de tiempo: 2 days
Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
2 days
Genotype for the MMP9-1562 C/T polymorphism
Periodo de tiempo: 1 days
  • Genetic polymorphism in the MMP9 coding region 1562C>T was screened following the polymerase chain reaction and restriction fragment length polymorphism (RFLP-PCR).
  • The frequency distributions of different MMP9-1562 C/T genotypes and allele were investigated.
  • The relationship between the polymorphism of the MMP-9 gene and the severity of PU was analyzed.
1 days
Genotyping of TNF- α G238A
Periodo de tiempo: 1 days
  • TNF-α G238A promoter polymorphism were determined by the RFLP-PCR method.
  • The genotypic and allelic frequencies of -238G/A were calculated
  • This study investigated the association between TNF-α-238G>A and Pressure ulcer in Tunisian population.
1 days
Genotyping of TNF- α G308A
Periodo de tiempo: 1 days
  • The genotypic analysis of the TNF-α G308A polymorphism was performed using Allele-specific PCR (AS-PCR) amplification.
  • In this study, we have analyzed the TNF-α gene promoter -308G/A polymorphism in Tunisian patients with PU to evaluate the contribution of this SNP in genetic susceptibility to PU.
1 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2013

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

9 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

14 de octubre de 2015

Publicado por primera vez (Estimar)

16 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de octubre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

14 de octubre de 2015

Última verificación

1 de octubre de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CHU Farhat Hached

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