The Effect Of Heel Protector In Intensive Care Units (EHePIcu)
Primary Purpose
Pressure Ulcer, Heel, Plantar Flexion Contracture of Tarsometatarsal Joint
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Effect Of Heel Protector In Intensive Care Units
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer, Heel focused on measuring Heel Pressure Ulcer, Plantar Flexion Contracture, Heel Protector
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
Sites / Locations
- Kübra ArslanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EHepIcu
Control Grubs
Arm Description
Outcomes
Primary Outcome Measures
Foot Joint Opening
goniometric measurement by the researcher
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05436340
Brief Title
The Effect Of Heel Protector In Intensive Care Units
Acronym
EHePIcu
Official Title
THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Heel, Plantar Flexion Contracture of Tarsometatarsal Joint
Keywords
Heel Pressure Ulcer, Plantar Flexion Contracture, Heel Protector
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EHepIcu
Arm Type
Experimental
Arm Title
Control Grubs
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
The Effect Of Heel Protector In Intensive Care Units
Intervention Description
In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
Heel pads will not be used in the control group. Routine maintenance will be applied
Primary Outcome Measure Information:
Title
Foot Joint Opening
Description
goniometric measurement by the researcher
Time Frame
for 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra Arslan
Phone
05549112925
Email
arslankbraa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebahat Ateş
Organizational Affiliation
Üsküdar Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Kübra Arslan
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kübra Arslan
Phone
05549112925
Email
arslankbraa@gmail.com
12. IPD Sharing Statement
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The Effect Of Heel Protector In Intensive Care Units
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