ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors for Pressure Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02578004
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
latifa, Centre Hôpital Universitaire Farhat Hached

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.

Condition or disease Intervention/treatment
Pressure Ulcers Other: biochemical and molecular analysis

Study Type : Observational
Actual Enrollment : 313 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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



Primary Outcome Measures :
  1. Anthropometric characteristics [ Time Frame: 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).

  2. Diabetes mellitus [ Time Frame: 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

  3. Dyslipidemia [ Time Frame: one hour ]
    • 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)

  4. Renal failure [ Time Frame: 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).

  5. Inflammatory parameter [ Time Frame: one hour ]
    - C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).

  6. Endogenous inflammatory marker [ Time Frame: one hour ]
    - α1‐acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)

  7. Markers of nutritional status [ Time Frame: one hour ]
    • 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).

  8. Marker of lipid peroxidation [ Time Frame: one day ]
    • 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.

  9. Antioxidant parameters [ Time Frame: one day ]
    - Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .

  10. Total antioxidant status [ Time Frame: 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 .

  11. Determination of trace elements [ Time Frame: 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.


  12. Nutritional status [ Time Frame: 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).

  13. Nutritional risk [ Time Frame: 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.


  14. A microbiological diagnosis [ Time Frame: 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.


  15. Proteomics [ Time Frame: 2 days ]
    - Serum gelatinase activities of MMP-9 by zymography (%)

  16. DNA extraction [ Time Frame: 2 days ]
    Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.

  17. Genotype for the MMP9-1562 C/T polymorphism [ Time Frame: 1 days ]
    • 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.

  18. Genotyping of TNF- α G238A [ Time Frame: 1 days ]
    • 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.

  19. Genotyping of TNF- α G308A [ Time Frame: 1 days ]
    • 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578004


Locations
Tunisia
Latifa KHLIFI
Sousse, Tunisia, 4000
Sponsors and Collaborators
Centre Hôpital Universitaire Farhat Hached

Responsible Party: latifa, PhD, Centre Hôpital Universitaire Farhat Hached
ClinicalTrials.gov Identifier: NCT02578004     History of Changes
Other Study ID Numbers: CHU Farhat Hached
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by latifa, Centre Hôpital Universitaire Farhat Hached:
Difficult
environmental, microbial, immunological and genetic factors
significantly different

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases