Pressure UlcerNCT04843618
Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt
An observational study of Pressure Ulcer, run by Cairo University.
Trial summary
the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Pressure Ulcer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jun 2022
- How long will I take part?
- 2 Weeks
- 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 25 to 65 years
- All sexes
- Adult, Older adult
Study population: cross-sectional study
Who may be able to join
- hospitalized patients will be selected from ICU and CCU
- both sexes males and females
- their age ranges between 25-65 years old
- patients who have peripheral arterial disease
- their body mass index (class II and class III obesity)
- diabetic patients more than 5 years old
Who cannot join
- medically unstable patients
- un cooperative patients
- semi- conscious or unconscious patients according to glascow coma scale
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence and Risk Factors of Pressure Ulcers in Hospitalized Patients in Beni Suef Governorate of Egypt
the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt
Read the detailed description
pressure ulcers are defined as localized damage to the skin as well as underlying soft tissue, usually occuring over a bony prominence or to medical devices.
immobility and friction are important risk factors for pressure ulcers, Malnutrition and body mass index are associated with pressure injury prevalence, the days in hospital, skin moisture and other neurological factors are significant risk factors for pressure ulcer development.
Beni-Suef is one of the upper Egypt governorates located about 120 Km south of cairo, according to population estimates from 2019, the majority of residents in the governorate live in rural areas, with an urbanization rate of only 23.2%, Due to greater reliance on federal and state payers, low volume and complxity of services provided, rural residents often encounter barriers to healthcare that limit their ability to obtain the care they need
- Conditions
- Pressure Ulcer
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
examine the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt
correlate between the prevalence and risk factors of pressure ulcers by using : sociodemographic variables, Braden risk scale assessment, clinical charactristics of the patient illness amd physical examination to assess the grade of pressure ulcer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohamed Mahmoud Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843618
- Sponsor's protocol ID
- pressure ulcers
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bergstrom N, Horn SD, Rapp M, Stern A, Barrett R, Watkiss M, Krahn M. Preventing Pressure Ulcers: A Multisite Randomized Controlled Trial in Nursing Homes. Ont Health Technol Assess Ser. 2014 Oct 1;14(11):1-32. eCollection 2014.
PubMed 26330893
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Pressure Ulcers in Hospitalized Patients in Beni Suef Governorate of Egypt
- ClinicalTrials.gov ID
- NCT04843618
- Acronym / sponsor ID
- pressure ulcers
- Conditions
- Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 13 Apr 2021 (actual)
- 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.
the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt
Detailed description
pressure ulcers are defined as localized damage to the skin as well as underlying soft tissue, usually occuring over a bony prominence or to medical devices.
immobility and friction are important risk factors for pressure ulcers, Malnutrition and body mass index are associated with pressure injury prevalence, the days in hospital, skin moisture and other neurological factors are significant risk factors for pressure ulcer development.
Beni-Suef is one of the upper Egypt governorates located about 120 Km south of cairo, according to population estimates from 2019, the majority of residents in the governorate live in rural areas, with an urbanization rate of only 23.2%, Due to greater reliance on federal and state payers, low volume and complxity of services provided, rural residents often encounter barriers to healthcare that limit their ability to obtain the care they need
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- cross-sectional study
Key inclusion criteria (6 listed)
- hospitalized patients will be selected from ICU and CCU
- both sexes males and females
- their age ranges between 25-65 years old
- patients who have peripheral arterial disease
- their body mass index (class II and class III obesity)
Key exclusion criteria (3 listed)
- medically unstable patients
- un cooperative patients
- semi- conscious or unconscious patients according to glascow coma scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
examine the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt
Time frame: baseline
correlate between the prevalence and risk factors of pressure ulcers by using : sociodemographic variables, Braden risk scale assessment, clinical charactristics of the patient illness amd physical examination to assess the grade of pressure ulcer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Results publication: PubMed 26330893Bergstrom N, Horn SD, Rapp M, Stern A, Barrett R, Watkiss M, Krahn M. Preventing Pressure Ulcers: A Multisite Randomized Controlled Trial in Nursing Homes. Ont Health Technol Assess Ser. 2014 Oct 1;14(11):1-32. eCollection 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by Cairo University.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Mohamed, master (01272663390, dreslam221@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
examine the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843618, which also lists 1 linked publication.
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 19 Apr 2021.