NCT06758674

Brief Summary

Pressure ulcers are wounds that typically occur on bony prominences, primarily due to external factors such as pressure, friction, and shear, as well as internal factors related to the patient. These ulcers can lead to serious health issues and have a high incidence rate, negatively impacting patients' quality of life, increasing hospitalization duration, and adding to healthcare costs. Prevention of pressure ulcers is considered an important indicator of care quality worldwide and in our country. International guidelines emphasize key points for preventing pressure ulcers, including risk assessment, skin assessment and care, nutrition, repositioning, support surface use, documentation, and education.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 27, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

pressure ulcernurseprevention

Outcome Measures

Primary Outcomes (1)

  • occurrence of pressure injury

    Patients will be evaluated for pressure ulcers three months after the end of the training. In patients with pressure ulcers, the site and stage of the wound will be recorded.

    3 months

Study Arms (2)

experimental group

EXPERIMENTAL

Patients assigned to the experimental group will first be informed about the study by phone and their participation status will be questioned. The relatives of the patients who want to participate in the study will be visited at home with the Home Health Services unit of Izmir Atatürk Training and Research Hospital and the data collection process and training will be carried out. After the training is given, the caregiver will be questioned about the applicability of the training content and the need for reminder training by calling the caregiver weekly in the first month and every two weeks in the second and third months for three months, and will be evaluated in terms of pressure sore formation, primarily in risky areas, during these interviews or by using the records of home health services.

Other: education

control group

NO INTERVENTION

Patients assigned to the control group must be home care patients who have registered with Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month, be over 18 years of age, be bedridden, and not have developed pressure sores on any part of their body. The caregivers of the patients assigned to the control group will be invited to the study by calling by phone, the introductory characteristics of the relatives of the patients who want to participate will be taken first, and the formation of pressure ulcers at the end of the first, second and third month without any training will be evaluated by calling by phone or by using the records of the Home Health Services Unit. At the end of the study, the patient / patient relatives assigned to the control group will also be given training to prevent pressure sores and a brochure will be given.

Interventions

Prepared in clear language and supported with visuals in line with guidelines and studies (Kottner et al. 2019, Orhan 2017, APUPA 2011, EPUAP and NPUAP 2009, EPUAP 2019, Arıkan and vanGiersbergen 2019, Arslantaş et al. 2018) training will be given to prevent pressure ulcers. Training content will be sent to expert opinion for content validity. In the content of the training, the definition of pressure ulcers, how they develop, high-risk areas for wound formation, identification of risks, evaluation of the skin, skin care, lying positions and position changes, supporting bone protrusions with pillows, lying on a support surface, nutritional status and content, fluid intake will be discussed.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Being a home care patient who has registered to Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month
  • Being over 18 years of age
  • Being bedridden
  • Not having pressure sores on any part of the body

You may not qualify if:

  • Patients who died during the data collection and follow-up process
  • Changed their home/changed caregivers and/or did not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Ataturk Training and Research Hospital

Izmir, Karabaglar, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 6, 2025

Study Start

November 1, 2024

Primary Completion

March 20, 2025

Study Completion

July 1, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations