Pressure InjuryNCT05541198
Prevention to Pressure Injury With Care Bundle
A study testing Pressure Injury Prevention Care Bundle in people with Pressure Injury, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study was conducted in order to evaluate of pressure injury prevention care bundle application in intensive care unit patients diagnosed with internal diseases. Background: Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Pressure Injury Prevention Care Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 16 Jun 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above,
- Who did not have any pressure injuries on any part of their body,
- Who were expected to stay in the clinic for at least 24 hours,
- Who were diagnosed with an internal disease
Who cannot join
- Who were younger than 18 years,
- Who had a pressure injury on any part of their body,
- Who were expected to stay in the clinic for less than 24 hours
- Who had intensive care indications other than an internal disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülnaz Altaş
Istanbul, Istanbul, Uskudar, Turkey, 34668
About this study
Official title: Evaluation of Pressure Injury Prevention Care Bundle Application in Intensive Care Unit Patients Diagnosed With Internal Diseases
Aim: The study was conducted in order to evaluate of pressure injury prevention care bundle application in intensive care unit patients diagnosed with internal diseases.
Background: Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions. Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles.
Design: Quasi-experimental and control group study. Methods: The study was conducted on 98 patients, 49 in the control group and 49 in the intervention group, diagnosed with internal diseases and hospitalized in the intensive care unit of a training and research hospital between July-December 2021. In the collection of the study data, patient information form, pressure injury prevention care bundle tool, and Braden Risk Scale were used. While routine clinical care continued to be provided to the patients in the control group, pressure injury prevention care bundle was applied to the patients in the intervention group.
Read the detailed description
As preventing the development of pressure injury is a parameter that shows the quality of care, the most significant responsibility in preventing pressure injury belongs to nurses. Pressure injury develops as a result of inadequate nursing care and not routinely applying evidence-based planned care in preventing pressure injury. In this sense, nurses can prevent the development of pressure injury by evaluating the patient holistically and applying evidence-based preventive pressure injury care.
Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions.In this context, European Pressure Injury Advisory Panel (EPIAP) and National Pressure Injury Advisory Panel (NPIAP) determined several preventive stages in order to prevent pressure injuries, such as risk assessment, skin assessment and care, repositioning, using pressure reducing surfaces, protection from incontinence, nutrition and fluid support, and training .
Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles. Care bundle is an organized and medical regulations-based set of applications that promotes compliance with guidelines and increases the quality of care by facilitating the provision of evidence-based care.
In the present study, it was aimed to prevent the development of pressure injuries by applying the prepared pressure injury prevention bundle care to the patients hospitalized in the intensive care unit patients diagnosed with internal diseases and thus to determine the effectiveness of the care bundle.
- Conditions
- Pressure Injury
- Being tested
- Pressure Injury Prevention Care Bundle
- Keywords
- Bundle care, Pressure injury, Intensive care, Nursing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Injury Prevention Care BundleOther
- Risk Assessment
- Skin Assessment
- Skin Care
- Positioning
- Regulation of Nutrition and Liquid Management
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; 1. Risk assessment using Braden Risk Scale 2. Positioning 3. Elevate the heels. |
| Intervention Group | Experimental | A pressure injury care bundle was developed in line with the relevant literature. After the development of the bundle, a 30-minute training program was applied to the nurses on general information about pressure injuries, the pressure injury care bundle, and how to use the bundle. The training program was carried out in four separate sessions arranged according to the working schedules of 40 nurses providing services in ICU.
Care Bundle include this parameters;
1. Risk Assessment
2. Skin Assessment
3. Skin Care
4. Positioning
5. Regulation of Nutrition and Liquid Management Receives: Other: Pressure Injury Prevention Care Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Measured: 60 minutes
Pressure Injury Prevention Care Bundle
Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.
Measured: 3-4 weeks
Braden Risk Assessment Tool
With this tool, six parameters of the patient's stimulant perception, activity, mobility, the effect caused on the skin by humidity, friction, and shearing tension are measured.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jul 2021
- Primary completion1 Dec 2021
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541198
- Sponsor's protocol ID
- GALTAS
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pressure Injury Prevention Care Bundle Application in Intensive Care Unit Patients Diagnosed With Internal Diseases
- ClinicalTrials.gov ID
- NCT05541198
- Acronym / sponsor ID
- GALTAS
- Conditions
- Pressure Injury
- Keywords
- Bundle care, Pressure injury, Intensive care, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 15 Sep 2022 (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.
Aim: The study was conducted in order to evaluate of pressure injury prevention care bundle application in intensive care unit patients diagnosed with internal diseases.
Background: Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions. Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles.
Design: Quasi-experimental and control group study. Methods: The study was conducted on 98 patients, 49 in the control group and 49 in the intervention group, diagnosed with internal diseases and hospitalized in the intensive care unit of a training and research hospital between July-December 2021. In the collection of the study data, patient information form, pressure injury prevention care bundle tool, and Braden Risk Scale were used. While routine clinical care continued to be provided to the patients in the control group, pressure injury prevention care bundle was applied to the patients in the intervention group.
Detailed description
As preventing the development of pressure injury is a parameter that shows the quality of care, the most significant responsibility in preventing pressure injury belongs to nurses. Pressure injury develops as a result of inadequate nursing care and not routinely applying evidence-based planned care in preventing pressure injury. In this sense, nurses can prevent the development of pressure injury by evaluating the patient holistically and applying evidence-based preventive pressure injury care.
Although a pressure injury is a problem that requires treatment for a long time and takes time to heal, it is possible to prevent it with appropriate interventions.In this context, European Pressure Injury Advisory Panel (EPIAP) and National Pressure Injury Advisory Panel (NPIAP) determined several preventive stages in order to prevent pressure injuries, such as risk assessment, skin assessment and care, repositioning, using pressure reducing surfaces, protection from incontinence, nutrition and fluid support, and training .
Evidence for the prevention of pressure injuries suggests using evidence-based guidelines or care bundles. Care bundle is an organized and medical regulations-based set of applications that promotes compliance with guidelines and increases the quality of care by facilitating the provision of evidence-based care.
In the present study, it was aimed to prevent the development of pressure injuries by applying the prepared pressure injury prevention bundle care to the patients hospitalized in the intensive care unit patients diagnosed with internal diseases and thus to determine the effectiveness of the care bundle.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; 1. Risk assessment using Braden Risk Scale 2. Positioning 3. Elevate the heels. |
| Intervention Group | Experimental | Other: Pressure Injury Prevention Care BundleA pressure injury care bundle was developed in line with the relevant literature. After the development of the bundle, a 30-minute training program was applied to the nurses on general information about pressure injuries, the pressure injury care bundle, and how to use the bundle. The training program was carried out in four separate sessions arranged according to the working schedules of 40 nurses providing services in ICU. Care Bundle include this parameters; 1. Risk Assessment 2. Skin Assessment 3. Skin Care 4. Positioning 5. Regulation of Nutrition and Liquid Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and above,
- Who did not have any pressure injuries on any part of their body,
- Who were expected to stay in the clinic for at least 24 hours,
- Who were diagnosed with an internal disease
Key exclusion criteria (4 listed)
- Who were younger than 18 years,
- Who had a pressure injury on any part of their body,
- Who were expected to stay in the clinic for less than 24 hours
- Who had intensive care indications other than an internal disease.
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 |
|---|---|---|
| Pressure Injury Prevention Care Bundle1. Risk Assessment 2. Skin Assessment 3. Skin Care 4. Positioning 5. Regulation of Nutrition and Liquid Management | Other | Intervention Group |
Primary outcome
Patient Information Form
Time frame: 60 minutes
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Pressure Injury Prevention Care Bundle
Time frame: 3-4 weeks
Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.
Braden Risk Assessment Tool
Time frame: 1 hour
With this tool, six parameters of the patient's stimulant perception, activity, mobility, the effect caused on the skin by humidity, friction, and shearing tension are measured.
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 15 Sep 2022.
- guidelinesLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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?
A study testing Pressure Injury Prevention Care Bundle in people with Pressure Injury, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 15 Sep 2022. 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 Turkey (Türkiye). 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?
Patient Information Form (time frame: 60 minutes). The study lists 3 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 15 Sep 2022.