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NCT05406986 Clinical Trial

The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit

Pressure Ulcer Clinical Trial

Official title:
The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05406986
Other study ID # Kilis7AralikUnivesity2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2022
Est. completion date October 15, 2022

Study information
Verified date June 2022
Source Kilis 7 Aralik University
Contact Erhan Elmaoglu
Phone +903488142666
Email erhan.elmaoglu@kilis.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 evaluation are needed to prevent these complications.This study aims to prevent pressure ulcers with a care package for patients with high risk scores.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date October 15, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 10 Years
Eligibility Inclusion Criteria: - being in the pediatric intensive care unit. - nasogastric tube, intubation tube and saturation probe attached. - Voluntary consent of family to participate in the study Exclusion Criteria: - Patients with skin disease - Patients staying less than 14 days

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• care bundle application
The patients in the experimental group will be given care according to the current care bundle for 14 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kilis 7 Aralik University

References & Publications (5)

Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485. Review. — View Citation

Curley 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. d — View Citation

Delmore 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. Review. — View Citation

Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4). pii: E25. doi: 10.3390/children4040025. Review. — View Citation

Puspitasari 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pressure ulcer Medical devices related pressure ulcer 14 day
Secondary 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. 14 day
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