NCT05541198

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 15, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

August 25, 2022

Last Update Submit

September 12, 2022

Conditions

Pressure Injury

Keywords

Bundle carePressure injuryIntensive careNursing

Outcome Measures

Primary Outcomes (3)

  • 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.

    60 minutes

  • Pressure Injury Prevention Care Bundle

    Care bundle includes risk assessment, skin assessment, skin care, repositioning, regulating nutrition and fluid intake.

    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.

    1 hour

Study Arms (2)

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

Other: Pressure Injury Prevention Care Bundle

Interventions

Pressure Injury Prevention Care BundleOTHER

1. Risk Assessment 2. Skin Assessment 3. Skin Care 4. Positioning 5. Regulation of Nutrition and Liquid Management

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülnaz Altaş

Istanbul, Istanbul, Uskudar, Turkey, 34668, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 15, 2022

Study Start

July 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 16, 2022

Last Updated

September 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)