Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559657
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine Wounds are seen in clinics as diabetic foot ulcers DFU arterial and venous ulcers pressure injuries surgical wounds and so on Pressure injuries PI have a high mortality rate 29 among elderly individuals The prevalence of PIs in different countries worldwide varies between 6 and 185 in acute care settings Wound assessment is an integral part of nursing practice
Improper assessment of wounds may lead to inadequate wound care resulting in delayed wound healing increased risk of infection increased costs and decreased patient quality of life Wound measurement is a useful quantitative finding in wound assessment used as a practical approach to monitor wound healing An ideal wound measurement method should be practical comfortable for the patient high accuracy reliability and applicability In clinical practice it is essential to regularly reassess wounds to monitor changes in size depth and appearance over time
With the emergence of new techniques and technologies there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types In addition there are hardly any studies comparing depth measurements with three-dimensional methods In this direction it was necessary to conduct this study in order to create evidence-based data in the field The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth
Improper assessment of wounds may lead to inadequate wound care resulting in delayed wound healing increased risk of infection increased costs and decreased patient quality of life Wound measurement is a useful quantitative finding in wound assessment used as a practical approach to monitor wound healing An ideal wound measurement method should be practical comfortable for the patient high accuracy reliability and applicability In clinical practice it is essential to regularly reassess wounds to monitor changes in size depth and appearance over time
With the emergence of new techniques and technologies there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types In addition there are hardly any studies comparing depth measurements with three-dimensional methods In this direction it was necessary to conduct this study in order to create evidence-based data in the field The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth
Detailed Description:
Hypotheses H1 There is concordance between digital planimetry and the imitoMeasure mobile application in measuring wound area
H2 There is concordance between digital planimetry and three-dimensional wound area measurement in measuring wound area
H3 There is concordance between the imitoMeasure mobile application and three-dimensional wound area measurement in measuring wound area
H4 There is concordance between measurement with a sterile cotton swab and three-dimensional wound measurement in assessing wound depth
Aim The aim of this study is to examine the concordance between digital planimetry the imitoMeasure mobile application and three-dimensional wound measurement methods in measuring the area of pressure injuries and to compare the measurement of wound depth using a sterile swab with the three-dimensional wound measurement method
Research Place and Time This study was conducted between April 2022 and April 2024 in the intensive care unit of the Department of Anesthesiology and Reanimation at Ege University Medical Faculty Hospital
Data Collection
For the purpose of data collection in this study the following were used the Individual and Wound Identification Form the Informed Consent Form the Digital Planimetry Device Visitrak the Smith Nephew Opsite Flexigrid Transparent Wound Dressing the imitoMeasure mobile application iPhone 13 the eKare inSight device and a Sterile Cotton Swab
H2 There is concordance between digital planimetry and three-dimensional wound area measurement in measuring wound area
H3 There is concordance between the imitoMeasure mobile application and three-dimensional wound area measurement in measuring wound area
H4 There is concordance between measurement with a sterile cotton swab and three-dimensional wound measurement in assessing wound depth
Aim The aim of this study is to examine the concordance between digital planimetry the imitoMeasure mobile application and three-dimensional wound measurement methods in measuring the area of pressure injuries and to compare the measurement of wound depth using a sterile swab with the three-dimensional wound measurement method
Research Place and Time This study was conducted between April 2022 and April 2024 in the intensive care unit of the Department of Anesthesiology and Reanimation at Ege University Medical Faculty Hospital
Data Collection
For the purpose of data collection in this study the following were used the Individual and Wound Identification Form the Informed Consent Form the Digital Planimetry Device Visitrak the Smith Nephew Opsite Flexigrid Transparent Wound Dressing the imitoMeasure mobile application iPhone 13 the eKare inSight device and a Sterile Cotton Swab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None