- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02578004
Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Sousse, Tunesien, 4000
- Latifa KHLIFI
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anthropometric characteristics
Tidsramme: 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
Tidsramme: 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
Tidsramme: one hour
|
|
one hour
|
|
Renal failure
Tidsramme: 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
Tidsramme: one hour
|
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
|
one hour
|
|
Endogenous inflammatory marker
Tidsramme: one hour
|
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
|
one hour
|
|
Markers of nutritional status
Tidsramme: one hour
|
|
one hour
|
|
Marker of lipid peroxidation
Tidsramme: one day
|
|
one day
|
|
Antioxidant parameters
Tidsramme: one day
|
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
|
one day
|
|
Total antioxidant status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 2 days
|
- Serum gelatinase activities of MMP-9 by zymography (%)
|
2 days
|
|
DNA extraction
Tidsramme: 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
Tidsramme: 1 days
|
|
1 days
|
|
Genotyping of TNF- α G238A
Tidsramme: 1 days
|
|
1 days
|
|
Genotyping of TNF- α G308A
Tidsramme: 1 days
|
|
1 days
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHU Farhat Hached
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .