Risk Factors for Pressure Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Other: biochemical and molecular analysis

• Study Type: Observational
• Enrollment (Actual): 313

Contacts and Locations

Study Locations

• Tunisia
  • Sousse, Tunisia, 4000
    • Latifa KHLIFI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: biochemical and molecular analysis
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.	Other: biochemical and molecular analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Inflammatory parameter	- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).	one hour
Endogenous inflammatory marker	- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)	one hour
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
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
Antioxidant parameters	- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .	one day
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
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
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
Nutritional risk	- 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	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	- Serum gelatinase activities of MMP-9 by zymography (%)	2 days
DNA extraction	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	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	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	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

Collaborators and Investigators

• Sponsor: Centre Hôpital Universitaire Farhat Hached

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Difficult; environmental, microbial, immunological and genetic factors; significantly different
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CHU Farhat Hached