- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02578004
Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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-
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Sousse, Tunisie, 4000
- Latifa KHLIFI
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Anthropometric characteristics
Délai: 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
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Diabetes mellitus
Délai: 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
Délai: one hour
|
|
one hour
|
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Renal failure
Délai: 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).
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one hour
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Inflammatory parameter
Délai: one hour
|
- 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
Délai: one hour
|
- 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
Délai: one hour
|
|
one hour
|
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Marker of lipid peroxidation
Délai: one day
|
|
one day
|
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Antioxidant parameters
Délai: one day
|
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
|
one day
|
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Total antioxidant status
Délai: 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
|
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Determination of trace elements
Délai: 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
Délai: 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
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Nutritional risk
Délai: 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
|
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A microbiological diagnosis
Délai: 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
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Proteomics
Délai: 2 days
|
- Serum gelatinase activities of MMP-9 by zymography (%)
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2 days
|
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DNA extraction
Délai: 2 days
|
Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
|
2 days
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Genotype for the MMP9-1562 C/T polymorphism
Délai: 1 days
|
|
1 days
|
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Genotyping of TNF- α G238A
Délai: 1 days
|
|
1 days
|
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Genotyping of TNF- α G308A
Délai: 1 days
|
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1 days
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CHU Farhat Hached
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