Risk Factors for Pressure Ulcers

NCT02578004 | Completed DMC

• 1 other identifier: CHU Farhat Hached
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcers

Keywords

Difficult; environmental, microbial, immunological and genetic factors; significantly different

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

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

Interventions

biochemical and molecular analysis OTHER

100 patients suffering from pressure ulcer; 213 healthy subjects

Eligibility Criteria

• Age: 19 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• paediatric study populations, age \> 90 years old, allergy to wound products, malignant origin

Sponsors & Collaborators

• Centre Hôpital Universitaire Farhat Hached: lead

Study Sites (1)

Latifa KHLIFI

Sousse, 4000, Tunisia

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 16, 2015
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

TU (1)