Clinical trial NCT05436340: The Effect Of Heel Protector In Intensive Care Units
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer, Heel
Plantar Flexion Contracture of Tarsometatarsal Joint
Keywords: Heel Pressure Ulcer
Plantar Flexion Contracture
Heel Protector
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Foot Joint Opening
timeFrame: for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kübra Arslan
Study officials:
affiliation: Üsküdar Üniversitesi
name: Sebahat Ateş
role: STUDY_DIRECTOR
References: