Pressure UlcersNCT02578004
Risk Factors for Pressure Ulcers
An observational study of Pressure Ulcers, run by Centre Hôpital Universitaire Farhat Hached at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 19 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- biochemical and molecular analysis
- How many people
- 313 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- paediatric study populations, age > 90 years old, allergy to wound products, malignant origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pressure Ulcers
- Being tested
- biochemical and molecular analysis
- Keywords
- Difficult, environmental, microbial, immunological and genetic factors, significantly different
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biochemical and molecular analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: biochemical and molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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)
Measured: 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).
Measured: one hour
Inflammatory parameter
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
Measured: one hour
Endogenous inflammatory marker
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
Measured: 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).
Measured: 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.
Measured: one day
Antioxidant parameters
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
Measured: 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 .
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 days
Proteomics
- Serum gelatinase activities of MMP-9 by zymography (%)
Measured: 2 days
DNA extraction
Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hôpital Universitaire Farhat Hached
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, latifa, Centre Hôpital Universitaire Farhat Hached
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578004
- Sponsor's protocol ID
- CHU Farhat Hached
- Status last verified
- Oct 2015
- First submitted
- 9 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
- ClinicalTrials.gov ID
- NCT02578004
- Acronym / sponsor ID
- CHU Farhat Hached
- Conditions
- Pressure Ulcers
- Keywords
- Difficult, environmental, microbial, immunological and genetic factors, significantly different
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Centre Hôpital Universitaire Farhat HachedUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients suffering from pressure ulcer | – | Other: biochemical and molecular analysis100 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. |
| 213 healthy subjects | – | Other: biochemical and molecular analysis213 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. |
Who may qualify
- Ages
- 19 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- paediatric study populations, age > 90 years old, allergy to wound products, malignant origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biochemical and molecular analysis | Other | 100 patients suffering from pressure ulcer, 213 healthy subjects |
Primary outcome
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).
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
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)
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).
Inflammatory parameter
Time frame: one hour
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
Endogenous inflammatory marker
Time frame: one hour
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
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).
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.
Antioxidant parameters
Time frame: one day
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
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 .
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.
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).
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.
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.
Proteomics
Time frame: 2 days
- Serum gelatinase activities of MMP-9 by zymography (%)
DNA extraction
Time frame: 2 days
Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers, run by Centre Hôpital Universitaire Farhat Hached at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric characteristics (time frame: one hour). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.