NCT06330506

Brief Summary

This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

March 19, 2024

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pressure ulcer formation

    The 'Pressure Ulcer Sites and Stages Follow-up Form' created by the researchers will be used. With this form, pressure ulcer stages and regions of the patients will be monitored.In this Form, pressure wound stages are classified into stages: Stage I, II, III, IV, Unstageable, Deep Tissue, and Mucosal Membrane Pressure Wound.

    Three days later

Study Arms (2)

Care group

EXPERIMENTAL

The pressure ulcer care package to be prepared by the researchers will be implemented

Other: Pressure ulcer prevention pack

Standard group

NO INTERVENTION

Standard maintenance will be applied

Interventions

The pressure ulcer prevention package to be prepared by the researchers will be applied

Care group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Orthopaedics and traumatology department
  • Those who have undergone general or spinal anesthesia
  • Without any communication problems
  • Patients who volunteered to participate in the study

You may not qualify if:

  • Patients with pre-operative pressure ulcer
  • Those who are bedridden
  • Patients referred to the intensive care unit after surgery
  • Patients who wish to leave the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dogubayazit Dr Yasar Eryılmaz State Hospital

Ağrı, 01030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Sevban Arslan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

April 10, 2024

Primary Completion

August 10, 2024

Study Completion

September 10, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations