Pressure UlcerNCT05406986
The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
A study testing care bundle application in people with Pressure Ulcer and Nursing Caries, run by Kilis 7 Aralik University.
Trial summary
With the development of technology in medicine, more medical instruments are used in the treatment of diseases. Although the use of these instruments provides great benefits for the patients, it can also cause some complications.One of the most important of these complications is pressure ulcer.Some care and… Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Nursing Caries, Device Induced Injury
- What is being tested?
- care bundle application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 15 Oct 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being in the pediatric intensive care unit.
- nasogastric tube, intubation tube and saturation probe attached.
- Voluntary consent of family to participate in the study
Who cannot join
- Patients with skin disease
- Patients staying less than 14 days
Trial locations and contacts
No sites are listed yet.
About this study
With the development of technology in medicine, more medical instruments are used in the treatment of diseases. Although the use of these instruments provides great benefits for the patients, it can also cause some complications.One of the most important of these complications is pressure ulcer.Some care and evaluation are needed to prevent these complications.This study aims to prevent pressure ulcers with a care package for patients with high risk scores.
Read the detailed description
A care package will be created with the Delphi method to prevent pressure ulcers caused by medical devices.Experimental and control groups will be formed by randomized control method.The care package created for 14 days will be applied to the experimental group. standard care will be applied to the control group.As a result, the rates of medical device-induced pressure ulcers in both groups will be compared.Children between the ages of 1 and 10 years and treated in the pediatric intensive care unit will be included in the study.Patients with any skin-related disease will not be included in the study.
- Conditions
- Pressure Ulcer, Nursing Caries, Device Induced Injury
- Being tested
- care bundle application
- Keywords
- medical devices, pressure ulcers, Care Bundles
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care bundle applicationOther
The patients in the experimental group will be given care according to the current care bundle for 14 days
| Study group | Role | What they receive |
|---|---|---|
| the group to which the care bundle will be applied | Experimental | Patients with a score of 13 or higher on the Braden QD medical instrument risk assessment scale.
Patients with attached nasogastric tube, intubation tube and saturation probe. Receives: Other: care bundle application |
| group not to be interfered with | No intervention | Patients with attached nasogastric tube, intubation tube and saturation probe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer
Medical devices related pressure ulcer
Measured: 14 day
Secondary outcomes (1)
medical device induced pressure ulcer
The rate of pressure ulcers caused by medical devices in the care package group will be compared with the rates of pressure ulcers caused by medical devices in patients receiving normal care.
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Experimental and control groups will be selected using the randomized control method.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Elmaoğlu, Kilis 7 Aralik University
- Investigators
- Zerrin Çiğdem, Principal investigator, Hasan Kalyoncu Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406986
- Sponsor's protocol ID
- Kilis7AralikUnivesity2022
- Status last verified
- Jun 2022
- First submitted
- 24 Apr 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected by the researcher will be shared with other participants. however, information about the patient will not be shared.
Publications
Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.
PubMed 18286861Curley MAQ, Hasbani NR, Quigley SM, Stellar JJ, Pasek TA, Shelley SS, Kulik LA, Chamblee TB, Dilloway MA, Caillouette CN, McCabe MA, Wypij D. Predicting Pressure Injury Risk in Pediatric Patients: The Braden QD Scale. J Pediatr. 2018 Jan;192:189-195.e2. doi: 10.1016/j.jpeds.2017.09.045.
PubMed 29246340Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.
PubMed 28387749Puspitasari JD, Nurhaeni N, Waluyanti FT. Testing of Braden QD Scale for predicting pressure ulcer risk in the Pediatric Intensive Care Unit. Pediatr Rep. 2020 Jun 25;12(Suppl 1):8694. doi: 10.4081/pr.2020.8694. eCollection 2020 Jun 25.
PubMed 32904968Delmore BA, Ayello EA. CE: Pressure Injuries Caused by Medical Devices and Other Objects: A Clinical Update. Am J Nurs. 2017 Dec;117(12):36-45. doi: 10.1097/01.NAJ.0000527460.93222.31.
PubMed 29120893
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05406986
- Acronym / sponsor ID
- Kilis7AralikUnivesity2022
- Conditions
- Pressure Ulcer, Nursing Caries, Device Induced Injury
- Keywords
- medical devices, pressure ulcers, Care Bundles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 7 Jun 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.
With the development of technology in medicine, more medical instruments are used in the treatment of diseases. Although the use of these instruments provides great benefits for the patients, it can also cause some complications.One of the most important of these complications is pressure ulcer.Some care and evaluation are needed to prevent these complications.This study aims to prevent pressure ulcers with a care package for patients with high risk scores.
Detailed description
A care package will be created with the Delphi method to prevent pressure ulcers caused by medical devices.Experimental and control groups will be formed by randomized control method.The care package created for 14 days will be applied to the experimental group. standard care will be applied to the control group.As a result, the rates of medical device-induced pressure ulcers in both groups will be compared.Children between the ages of 1 and 10 years and treated in the pediatric intensive care unit will be included in the study.Patients with any skin-related disease will not be included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental and control groups will be selected using the randomized control method.
| Arm | Type | Receives |
|---|---|---|
| the group to which the care bundle will be applied | Experimental | Other: care bundle applicationPatients with a score of 13 or higher on the Braden QD medical instrument risk assessment scale. Patients with attached nasogastric tube, intubation tube and saturation probe. |
| group not to be interfered with | No intervention | –Patients with attached nasogastric tube, intubation tube and saturation probe. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being in the pediatric intensive care unit.
- nasogastric tube, intubation tube and saturation probe attached.
- Voluntary consent of family to participate in the study
Key exclusion criteria (2 listed)
- Patients with skin disease
- Patients staying less than 14 days
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 |
|---|---|---|
| care bundle applicationThe patients in the experimental group will be given care according to the current care bundle for 14 days | Other | the group to which the care bundle will be applied |
Primary outcome
Pressure ulcer
Time frame: 14 day
Medical devices related pressure ulcer
1 secondary outcome
medical device induced pressure ulcer
Time frame: 14 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Results publication: PubMed 18286861Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.
- Results publication: PubMed 29246340Curley MAQ, Hasbani NR, Quigley SM, Stellar JJ, Pasek TA, Shelley SS, Kulik LA, Chamblee TB, Dilloway MA, Caillouette CN, McCabe MA, Wypij D. Predicting Pressure Injury Risk in Pediatric Patients: The Braden QD Scale. J Pediatr. 2018 Jan;192:189-195.e2. doi: 10.1016/j.jpeds.2017.09.045.
- Results publication: PubMed 28387749Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.
- Results publication: PubMed 32904968Puspitasari JD, Nurhaeni N, Waluyanti FT. Testing of Braden QD Scale for predicting pressure ulcer risk in the Pediatric Intensive Care Unit. Pediatr Rep. 2020 Jun 25;12(Suppl 1):8694. doi: 10.4081/pr.2020.8694. eCollection 2020 Jun 25.
- Results publication: PubMed 29120893Delmore BA, Ayello EA. CE: Pressure Injuries Caused by Medical Devices and Other Objects: A Clinical Update. Am J Nurs. 2017 Dec;117(12):36-45. doi: 10.1097/01.NAJ.0000527460.93222.31.
- Individual participant dataSharing planned: No. The data collected by the researcher will be shared with other participants. however, information about the patient will not be shared.
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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.
Zerrin Çiğdem principal investigator
Hasan Kalyoncu Univesity
Questions about this trial
What is this clinical trial studying?
A study testing care bundle application in people with Pressure Ulcer and Nursing Caries, run by Kilis 7 Aralik 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 2 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 7 Jun 2022. 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 Erhan Elmaoğlu (+903488142666, erhan.elmaoglu@kilis.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer (time frame: 14 day). 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 NCT05406986, which also lists 5 linked publications.
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 7 Jun 2022.