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

June 4, 2022 updated by: Erhan Elmaoğlu, Kilis 7 Aralik University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the group to which the care bundle will be applied

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.
Other: care bundle application
The patients in the experimental group will be given care according to the current care bundle for 14 days
No Intervention: group not to be interfered with
Patients with attached nasogastric tube, intubation tube and saturation probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure ulcer
Time Frame: 14 day
Medical devices related pressure ulcer
14 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medical device induced pressure ulcer
Time Frame: 14 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kilis 7 Aralik University

Investigators

  • Principal Investigator: Zerrin Çiğdem, Hasan Kalyoncu Univesity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2022

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

April 24, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kilis7AralikUnivesity2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected by the researcher will be shared with other participants. however, information about the patient will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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