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临床试验/NCT02578004
NCT02578004已完成不适用

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

Centre Hôpital Universitaire Farhat Hached1 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
313
试验地点
1
主要终点
Anthropometric characteristics

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Anthropometric characteristics

时间窗: 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).

Antioxidant parameters

时间窗: one day

- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .

Dyslipidemia

时间窗: 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)

Renal failure

时间窗: 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).

Endogenous inflammatory marker

时间窗: one hour

- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)

Marker of lipid peroxidation

时间窗: 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.

Total antioxidant status

时间窗: 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 .

Determination of trace elements

时间窗: 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.

Nutritional risk

时间窗: 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.

DNA extraction

时间窗: 2 days

Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.

Nutritional status

时间窗: 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).

A microbiological diagnosis

时间窗: 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.

Proteomics

时间窗: 2 days

- Serum gelatinase activities of MMP-9 by zymography (%)

Genotype for the MMP9-1562 C/T polymorphism

时间窗: 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.

Diabetes mellitus

时间窗: 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

Inflammatory parameter

时间窗: one hour

- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).

Markers of nutritional status

时间窗: 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).

Genotyping of TNF- α G238A

时间窗: 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.

Genotyping of TNF- α G308A

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Centre Hôpital Universitaire Farhat Hached
申办方类型
Other
责任方
Principal Investigator
主要研究者

latifa

PhD

Centre Hôpital Universitaire Farhat Hached

研究点 (1)

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