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NCT Number: NCT06559657

Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries

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.

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Key information

Conditions

Pressure Injury Innovativeness Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eKare Insight, imitoMeasure Mobile App, Visitrak

Device

The wound size of the patients was measured with three different methods. Wound depth was measured using manual method and three-dimensional imaging devices.

Primary outcomes

  1. Wound area measurment

    Time frame: Approximately 5 minutes until the wound is selected and the measurement is completed.

    It is the measurement of wound area with three different methods.

  2. Wound depth measurment

    Time frame: Approximately 5 minutes until the wound is selected and the measurement is completed.

    It is the measurement of wound depth with two different methods.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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