Risk Factors for Pressure Ulcers

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578004
• Other study ID #: CHU Farhat Hached
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 14, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Centre Hôpital Universitaire Farhat Hached
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tasnim masmoudi: Tunisia
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: June 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 88 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Other:
• biochemical and molecular analysis

Locations

Country	Name	City	State
Tunisia	Latifa KHLIFI	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hôpital Universitaire Farhat Hached

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric characteristics	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	Yes
Primary	Diabetes mellitus	- 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	Yes
Primary	Dyslipidemia	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	Yes
Primary	Renal failure	- 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	Yes
Primary	Inflammatory parameter	- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).	one hour	Yes
Primary	Endogenous inflammatory marker	- a1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)	one hour	Yes
Primary	Markers of nutritional status	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	Yes
Primary	Marker of lipid peroxidation	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	Yes
Primary	Antioxidant parameters	- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .	one day	Yes
Primary	Total antioxidant status	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	Yes
Primary	Determination of trace elements	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	Yes
Primary	Nutritional status	- 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	Yes
Primary	Nutritional risk	- Prognostic Inflammatory and Nutritional Index (PINI) is a simple clinical [PINI = AAG x CRP / albumine x prealbumin] and classificated as follows: normal (1These scores gained in popularity as it uses an objective rather than subjective measurements to determine nutritional risk in hospitalized patient populations.	3 hours	Yes
Primary	A microbiological diagnosis	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	Yes
Primary	Proteomics	- Serum gelatinase activities of MMP-9 by zymography (%)	2 days	Yes
Primary	DNA extraction	Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.	2 days	Yes
Primary	Genotype for the MMP9-1562 C/T polymorphism	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	Yes
Primary	Genotyping of TNF- a G238A	TNF-a 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-a-238G>A and Pressure ulcer in Tunisian population.	1 days	Yes
Primary	Genotyping of TNF- a G308A	The genotypic analysis of the TNF-a G308A polymorphism was performed using Allele-specific PCR (AS-PCR) amplification.; In this study, we have analyzed the TNF-a gene promoter -308G/A polymorphism in Tunisian patients with PU to evaluate the contribution of this SNP in genetic susceptibility to PU.	1 days	Yes