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Clinical Trials/NCT05436340
NCT05436340
Recruiting
Not Applicable

THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS

Maltepe University1 site in 1 country84 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcer, Heel
Sponsor
Maltepe University
Enrollment
84
Locations
1
Primary Endpoint
Foot Joint Opening
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time.

Design: The study is conducted as a Randomized Controlled Study. Method: Heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. As calculated in the G-Power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. These patients will be followed for a total of 14 days. Heel Scalp Evaluation and Goniometric Measurements will be made according to Braden Pressure Wound Risk Assessment Scale, Ramsey Sedation Scale, NPUAP and EPUAP Staging System and recorded in the data collection form created by the researcher.

H1: The heel protector is effective in preventing heel pressure ulcer. H0: The heel protector has no effect on preventing heel pressure ulcer. H2: The heel protector is effective in preventing plantar flexion contracture. H0: The heel protector has no effect on preventing plantar flexion contracture. H3: The heel protector is effective in improving the joint range of patients with plantar flexion contracture.

H0: The heel protector has no effect on improving joint range in patients with plantar flexion contracture.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
December 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kübra Arslan

Master's Student

Maltepe University

Eligibility Criteria

Inclusion Criteria

  • High-risk patients; patients who were intubated or extubated in the ICU for at least 5 days and received sedation
  • Patients with Braden Pressure Sore Risk Assessment Scale 16 and below
  • Patients with a Ramsey Sedation Scale of 4 and above

Exclusion Criteria

  • BMI over 30
  • Patients with vascular disease
  • Patients with albumin level below 2.5 mg/dL
  • Patients mobile within 5 days
  • Patients hospitalized with heel pressure ulcer
  • Despite being included in the study, the patient becomes mobile before 15 days
  • Patients with a medical condition that contraindicates the use of heel protectors

Outcomes

Primary Outcomes

Foot Joint Opening

Time Frame: for 14 days

goniometric measurement by the researcher

Study Sites (1)

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