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Risk Factors for Pressure Ulcers

14 de outubro de 2015 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

313

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Sousse, Tunísia, 4000
        • Latifa KHLIFI

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos a 88 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Controle de caso
  • Perspectivas de Tempo: Retrospectivo

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Anthropometric characteristics
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: one hour
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
one hour
Endogenous inflammatory marker
Prazo: one hour
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
one hour
Markers of nutritional status
Prazo: 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
Prazo: 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
Prazo: one day
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
one day
Total antioxidant status
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 2 days
- Serum gelatinase activities of MMP-9 by zymography (%)
2 days
DNA extraction
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2013

Conclusão Primária (Real)

1 de abril de 2014

Conclusão do estudo (Real)

1 de junho de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

9 de outubro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de outubro de 2015

Primeira postagem (Estimativa)

16 de outubro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

16 de outubro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de outubro de 2015

Última verificação

1 de outubro de 2015

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CHU Farhat Hached

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