The Effect Of Heel Protector In Intensive Care Units
EHePIcu
THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
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
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 1, 2022
October 1, 2022
10 months
June 23, 2022
October 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Foot Joint Opening
goniometric measurement by the researcher
for 14 days
Study Arms (2)
EHepIcu
EXPERIMENTALControl Grubs
NO INTERVENTIONInterventions
In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.
Heel pads will not be used in the control group. Routine maintenance will be applied
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kübra Arslan
Kocaeli, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sebahat Ateş
Üsküdar Üniversitesi
Central Study Contacts
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
- Master's Student
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 29, 2022
Study Start
February 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10