The Effect Of Heel Protector In Intensive Care Units | NCT05436340

Studies
The Effect Of Heel Protector In Intensive Care Units

NCT05436340

Sponsor

Maltepe University

Status

Unknown status

Last Update Posted

Nov 1, 2022Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Pressure Ulcer, Heel
Plantar Flexion Contracture of Tarsometatarsal Joint

Interventions

The Effect Of Heel Protector In Intensive Care Units
Control group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jun 23, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2022

Last Update Posted Date

Nov 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EHepIcu	Experimental		Device: The Effect Of Heel Protector In Intensive Care Units Device: Control group
Control Grubs	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Effect Of Heel Protector In Intensive Care Units	Device	In the experimental group, foot joint opening and heel pressure sore formation will be observed by using heel protector pad.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Foot Joint Opening	goniometric measurement by the researcher	for 14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kübra Arslan	Contact	05549112925		arslankbraa@gmail.com

Overall Officials

Name	Affiliation	Role
Sebahat Ateş	Uskudar University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kübra Arslan	Recruiting	Kocaeli			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided