EHePIcu: The Effect Of Heel Protector In Intensive Care Units

• Sponsor: Maltepe University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05436340
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 9.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer, Heel; Plantar Flexion Contracture of Tarsometatarsal Joint	Device: The Effect Of Heel Protector In Intensive Care Units; Device: Control group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EHepIcu	Device: The Effect Of Heel Protector In Intensive Care Units; In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.; Device: Control group; Heel pads will not be used in the control group. Routine maintenance will be applied
No Intervention: Control Grubs

Outcome Measures

Primary Outcome Measures

1. Foot Joint Opening [for 14 days]

   goniometric measurement by the researcher

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kübra Arslan	Kocaeli		Turkey

Sponsors and Collaborators

• Maltepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kübra Arslan, Master's Student, Maltepe University
• ClinicalTrials.gov Identifier: NCT05436340
• Other Study ID Numbers: 2021/33-20
• First Posted: Jun 29, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kübra Arslan, Master's Student, Maltepe University: Heel Pressure Ulcer; Plantar Flexion Contracture; Heel Protector
• Additional relevant MeSH terms: Contracture; Pressure Ulcer

Study Results

No Results Posted as of Jul 26, 2022