- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436340
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kübra Arslan
- Phone Number: 05549112925
- Email: arslankbraa@gmail.com
Study Locations
-
-
-
Kocaeli, Turkey
- Recruiting
- Kübra Arslan
-
Contact:
- Kübra Arslan
- Phone Number: 05549112925
- Email: arslankbraa@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EHepIcu
|
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
|
No Intervention: Control Grubs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Joint Opening
Time Frame: for 14 days
|
goniometric measurement by the researcher
|
for 14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sebahat Ateş, Üsküdar Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/33-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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