Skip to main content
Clinical Trials/NCT06559657
NCT06559657CompletedNot Applicable

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

Ege University2 sites in 2 countries125 target enrollmentStarted: August 12, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
125
Locations
2
Primary Endpoint
Wound area measurment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gul SAHBUDAK

Research assistant at the Department of Nursing Principles

Ege University

Study Sites (2)

Loading locations...

Similar Trials

Investigation of the Consistency Between... | Clinical Trial