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Risk Factors for Pressure Ulcers

14 ottobre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

313

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Sousse, Tunisia, 4000
        • Latifa KHLIFI

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 19 anni a 88 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Caso di controllo
  • Prospettive temporali: Retrospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2013

Completamento primario (Effettivo)

1 aprile 2014

Completamento dello studio (Effettivo)

1 giugno 2015

Date di iscrizione allo studio

Primo inviato

9 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

14 ottobre 2015

Primo Inserito (Stima)

16 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 ottobre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 ottobre 2015

Ultimo verificato

1 ottobre 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CHU Farhat Hached

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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