Clinical trial NCT06559657: Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries
Official title: Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Innovativeness
Wound
Keywords: Pressure Ulcer
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 18.5% 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.

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."

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Volunteering to participate in research,
* Having at least Stage 2 pressure injury

Exclusion Criteria:

* Having Stage 1 pressure injuries
* Having a wound with a shape that makes 2D area measurement impossible
* Patients who cannot remain in the same position for a long time

Primary outcomes:
measure: Wound area measurment
timeFrame: Approximately 5 minutes until the wound is selected and the measurement is completed.
measure: Wound depth measurment
timeFrame: Approximately 5 minutes until the wound is selected and the measurement is completed.
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References:
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citation: Pena G, Kuang B, Szpak Z, Cowled P, Dawson J, Fitridge R. Evaluation of a Novel Three-Dimensional Wound Measurement Device for Assessment of Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2020 Nov;9(11):623-631. doi: 10.1089/wound.2019.0965. Epub 2019 Oct 23.