Pressure UlcerIdealSkinCaresNCT06369688
IDEAL SKIIN CARES Bundle to Prevent Pressure Injury
A study testing IDEAL SKIIN CARES bundles, IDEAL SKIIN CARES bundles workshop and Respiratory care workshop in people with Pressure Ulcer and Pressure Injury, run by Baqiyatallah Medical Sciences University.
Trial summary
The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Pressure Injury, Bed Sore
- What is being tested?
- IDEAL SKIIN CARES bundles, IDEAL SKIIN CARES bundles workshop and Respiratory care workshop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,620 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be adults aged 18 years or older;
- have been hospitalized for a minimum of 48 hours;
- be willing to participate.
Who cannot join
- patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;
- have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);
- be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);
- individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;
- patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;
- admitted to the hospital for >28 days;
- those with prior experience of PIs or training in PIs care and prevention.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial
The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.
Read the detailed description
The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities. These components are categorized into three groups to facilitate understanding and enhance patient engagement in PIP care: (1) Education; (2) assessment of patient's condition; and (3) Care intervention. Therefore, the investigators will conduct a c-RCT with three arm parallel design for hospitalized patients to assessed the effect of IDEAL SKIIN CARES bundle to prevent of occurrence HAPI in three groups of study and compare with routine standard care for PIP care bundle.
- Conditions
- Pressure Ulcer, Pressure Injury, Bed Sore, Pressure Sore, Decubitus Sore, Decubitus Ulcer
- Being tested
- IDEAL SKIIN CARES bundles, IDEAL SKIIN CARES bundles workshop, Respiratory care workshop
- Keywords
- Pressure Injury, Care Bundle, Hospital-acquired pressure injury, Randomized Clinical Trial, IDEAL SKIIN CARES
- Medical subject headings
- Pressure Ulcer, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEAL SKIIN CARES bundlesOther
The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in the intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities.
IDEAL SKIIN CARES bundles workshopOther
IDEAL SKIIN CARES bundles will be explained in detail by a trained research assistant in a workshop. This workshop is different from clinical training and following up about the IDEAL SKIIN CARES bundles.
Respiratory care workshopOther
An unrelated topic, specifically respiratory care will be held in a workshop. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Educational packages including a pamphlet, brochure, and visual poster that outlines three key components of the IDEAL SKIIN CARES bundle (Education, Assessment of patient's condition and Care intervention) will be provided along with sub-items. These materials will be explained in detail by a trained research assistant in a workshop. Patients will be encouraged by the research assistant to actively participate in PIP self-care activities following the IDEAL SKIIN CARES approach shortly after recruitment and will continue to provide patient education throughout the study period. This training will begin before data collection and will be maintained as needed. Each hospital's study investigator will oversee the training activities at their site to guarantee consistency and adherence to the intervention protocol. In addition, patients will receive the IDEAL SKIIN CARES bundle from WSNs. Receives: Other: IDEAL SKIIN CARES bundles; Other: IDEAL SKIIN CARES bundles workshop |
| Placebo group | Placebo comparator | The placebo group will receive training in an unrelated topic, specifically respiratory care. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care, mirroring the approach taken with the intervention group. Despite the focus on respiratory care education, patients in the placebo group will also benefit from specialized PIP care through the IDEAL SKIIN CARES bundle, administered by trained WSNs. These WSNs will provide interventions focused on PIP strategies based on the IDEAL SKIIN CARES bundle, ensuring that patients in the placebo group receive comprehensive wound care support throughout the study period. Receives: Other: IDEAL SKIIN CARES bundles; Other: Respiratory care workshop |
| Control group | No intervention | The control group will not receive any relevant or irrelevant training or educational materials. They will only receive routine standard care for the PIP care bundle, following the care plans as routine by the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital-acquired pressure injury (HAPI)
All patients in the three groups will be closely monitored for the development of HAPI. Two independent and experienced WSNs will oversee the intervention and placebo groups, while two independent and experienced research assistants will supervise the control group. They will conduct separate examinations of the patients to assess the presence or absence of PI, following the NPUAP guidelines. These assessments will occur three times a day during morning, evening, and night shifts to ensure comprehensive monitoring of at-risk patients, and with daily evaluations for patients without PI risk factors. The occurrence time of PI will be recorded for each patient based on the day. To ensure consistency and accuracy in PI assessment, the agreement between the two assessors will be evaluated using the Kappa agreement test for inter-rater reliability
Measured: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Secondary outcomes (4)
Pressure Injury Stage
Wound specialist nurses and experienced research assistants will determine the stage of PIs among patients and monitor the progression of PI stages (increased severity in PI stages) in all three study groups. The stages of a pressure ulcer typically range from Stage 1 to Stage 4, with each stage indicating the severity of tissue damage. The assessment of PI stages will involve evaluating factors such as skin integrity, tissue involvement, and the presence of necrosis. Any changes in the stage of a PI will be carefully documented to track the progression of the injury over time. To ensure consistency and accuracy in PI stage determination, the agreement between the two assessors will be evaluated using the Kappa agreement test for inter-rater reliability on stage of PI.
Measured: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Patient participation in care
When patients reach the trial endpoint, the assessor (the research assistants and WSNs) will utilize the Patient Participation Scale as a secondary outcome measure.
Measured: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Healthcare costs
The costs linked to providing the IDEAL SKIIN CARES bundle, including time spent on patient education, training WSNs, and developing educational resources like brochures, posters, and pamphlets, will be gathered for all participants in the trial. Additionally, data on the length of hospital stays will be collected. Over a 28-day observational period, detailed micro-costing data will be collected by a dedicated research assistant. Specifically, the number of repositioning episodes per participant, the clinical staff required for repositioning, and the nurse time needed per repositioning will be determined. Other resources utilized for IDEAL SKIIN CARES or standard care bundles, such as special mattresses, skincare products, and incontinence care, will also be documented. The direct costs will then be allocated to each resource unit using established costing references.
Measured: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Self-report Patient participation in care
Patients will be asked to self-report their level of participation in PIP by providing a score from 0 to 10. This self-assessment will offer insights into the patient's perception of their involvement in their care plan.
Measured: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences, Hamadan University of Medical Science, Tabriz University of Medical Sciences
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir vahedian-azimi, Professor, Principal investigator, Baqiyatallah University of Medical Sciences, Tehran, Iran.Keivan Goharimoghadam, Professor, Study director, Tehran University of Medical Scienecs, Tehran, IranFarshid Rahimi-bashar, Professor, Study director, Hamadan University of Medical Sciences, Hamadan, Iran.Ata Mahmoodpoor, Professor, Study director, Tabriz university of Medical Sciences, Tabriz, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369688
- Sponsor's protocol ID
- Baqiyatallah University
- Acronym
- IdealSkinCares
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bahramnezhad F, Probst S, Moradi A, Gohari-Moghadam K, Rahimi-Bashar F, Mahmoodpoor A, Ghamari AA, Jafari I, Vahedian-Azimi A, Pokorna A. Development and validation of the Pressure Injury after Hospital Admission (PIAHA) screening tool for early assessment of hospital-acquired pressure injuries: a multiphase multicentre study protocol in acute care settings. BMJ Open. 2026 Mar 26;16(3):e114550. doi: 10.1136/bmjopen-2025-114550.
PubMed 41887642
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06369688
- Acronym / sponsor ID
- IdealSkinCares / Baqiyatallah University
- Conditions
- Pressure Ulcer, Pressure Injury, Bed Sore, Pressure Sore, Decubitus Sore, Decubitus Ulcer
- Keywords
- Pressure Injury, Care Bundle, Hospital-acquired pressure injury, Randomized Clinical Trial, IDEAL SKIIN CARES
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,620 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences, Hamadan University of Medical Science, Tabriz University of Medical Sciences
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Apr 2024 (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 will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.
Detailed description
The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities. These components are categorized into three groups to facilitate understanding and enhance patient engagement in PIP care: (1) Education; (2) assessment of patient's condition; and (3) Care intervention. Therefore, the investigators will conduct a c-RCT with three arm parallel design for hospitalized patients to assessed the effect of IDEAL SKIIN CARES bundle to prevent of occurrence HAPI in three groups of study and compare with routine standard care for PIP care bundle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: IDEAL SKIIN CARES bundles, Other: IDEAL SKIIN CARES bundles workshopEducational packages including a pamphlet, brochure, and visual poster that outlines three key components of the IDEAL SKIIN CARES bundle (Education, Assessment of patient's condition and Care intervention) will be provided along with sub-items. These materials will be explained in detail by a trained research assistant in a workshop. Patients will be encouraged by the research assistant to actively participate in PIP self-care activities following the IDEAL SKIIN CARES approach shortly after recruitment and will continue to provide patient education throughout the study period. This training will begin before data collection and will be maintained as needed. Each hospital's study investigator will oversee the training activities at their site to guarantee consistency and adherence to the intervention protocol. In addition, patients will receive the IDEAL SKIIN CARES bundle from WSNs. |
| Placebo group | Placebo comparator | Other: IDEAL SKIIN CARES bundles, Other: Respiratory care workshopThe placebo group will receive training in an unrelated topic, specifically respiratory care. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care, mirroring the approach taken with the intervention group. Despite the focus on respiratory care education, patients in the placebo group will also benefit from specialized PIP care through the IDEAL SKIIN CARES bundle, administered by trained WSNs. These WSNs will provide interventions focused on PIP strategies based on the IDEAL SKIIN CARES bundle, ensuring that patients in the placebo group receive comprehensive wound care support throughout the study period. |
| Control group | No intervention | –The control group will not receive any relevant or irrelevant training or educational materials. They will only receive routine standard care for the PIP care bundle, following the care plans as routine by the hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be adults aged 18 years or older;
- have been hospitalized for a minimum of 48 hours;
- be willing to participate.
Key exclusion criteria (7 listed)
- patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;
- have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);
- be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);
- individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;
- patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;
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 |
|---|---|---|
| IDEAL SKIIN CARES bundlesThe investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in the intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities. | Other | Intervention group, Placebo group |
| IDEAL SKIIN CARES bundles workshopIDEAL SKIIN CARES bundles will be explained in detail by a trained research assistant in a workshop. This workshop is different from clinical training and following up about the IDEAL SKIIN CARES bundles. | Other | Intervention group |
| Respiratory care workshopAn unrelated topic, specifically respiratory care will be held in a workshop. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care | Other | Placebo group |
Primary outcome
Incidence of hospital-acquired pressure injury (HAPI)
Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
All patients in the three groups will be closely monitored for the development of HAPI. Two independent and experienced WSNs will oversee the intervention and placebo groups, while two independent and experienced research assistants will supervise the control group. They will conduct separate examinations of the patients to assess the presence or absence of PI, following the NPUAP guidelines. These assessments will occur three times a day during morning, evening, and night shifts to ensure comprehensive monitoring of at-risk patients, and with daily evaluations for patients without PI risk factors. The occurrence time of PI will be recorded for each patient based on the day. To ensure consistency and accuracy in PI assessment, the agreement between the two assessors will be evaluated using the Kappa agreement test for inter-rater reliability
4 secondary outcomes
Pressure Injury Stage
Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Patient participation in care
Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Healthcare costs
Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Self-report Patient participation in care
Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 41887642Bahramnezhad F, Probst S, Moradi A, Gohari-Moghadam K, Rahimi-Bashar F, Mahmoodpoor A, Ghamari AA, Jafari I, Vahedian-Azimi A, Pokorna A. Development and validation of the Pressure Injury after Hospital Admission (PIAHA) screening tool for early assessment of hospital-acquired pressure injuries: a multiphase multicentre study protocol in acute care settings. BMJ Open. 2026 Mar 26;16(3):e114550. doi: 10.1136/bmjopen-2025-114550.
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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.
Amir vahedian-azimi, Professor principal investigator
Baqiyatallah University of Medical Sciences, Tehran, Iran.
Keivan Goharimoghadam, Professor study director
Tehran University of Medical Scienecs, Tehran, Iran
Farshid Rahimi-bashar, Professor study director
Hamadan University of Medical Sciences, Hamadan, Iran.
Questions about this trial
What is this clinical trial studying?
A study testing IDEAL SKIIN CARES bundles, IDEAL SKIIN CARES bundles workshop and Respiratory care workshop in people with Pressure Ulcer and Pressure Injury, run by Baqiyatallah Medical Sciences 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir vahedian-azimi, Professor (09196017138 ext. 0098, amirvahedian63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital-acquired pressure injury (HAPI) (time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days). 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 NCT06369688, 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 17 Apr 2024.