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

NCT06559657 | Completed DMC

• 1 other identifier: Nursing Faculty
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Innovativeness; Wound

Keywords

Pressure Ulcer

Outcome Measures

Primary Outcomes (2)

• Wound area measurment

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

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

• Wound depth measurment

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

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

Study Arms (1)

Wound area and depth measurement

EXPERIMENTAL

The area of the pressure injuries was measured using digital planimetry, the imitoMeasure mobile application, and the three-dimensional wound measurement method. Depth was measured using a sterile cotton swab and the three-dimensional wound measurement method.

Device: eKare Insight, imitoMeasure Mobile App, Visitrak

Interventions

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.

Wound area and depth measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (9)

• Magny E, Vallet H, Cohen-Bittan J, Raux M, Meziere A, Verny M, Riou B, Khiami F, Boddaert J. Pressure ulcers are associated with 6-month mortality in elderly patients with hip fracture managed in orthogeriatric care pathway. Arch Osteoporos. 2017 Aug 29;12(1):77. doi: 10.1007/s11657-017-0365-9.

  PMID: 28852954 RESULT

• Anisuzzaman DM, Wang C, Rostami B, Gopalakrishnan S, Niezgoda J, Yu Z. Image-Based Artificial Intelligence in Wound Assessment: A Systematic Review. Adv Wound Care (New Rochelle). 2022 Dec;11(12):687-709. doi: 10.1089/wound.2021.0091. Epub 2021 Dec 20.

  PMID: 34544270 RESULT

• Tervo-Heikkinen TA, Heikkila A, Koivunen M, Kortteisto TR, Peltokoski J, Salmela S, Sankelo M, Ylitormanen TS, Junttila K. Pressure injury prevalence and incidence in acute inpatient care and related risk factors: A cross-sectional national study. Int Wound J. 2022 May;19(4):919-931. doi: 10.1111/iwj.13692. Epub 2021 Oct 4.

  PMID: 34605185 RESULT

• Tubaishat A, Papanikolaou P, Anthony D, Habiballah L. Pressure Ulcers Prevalence in the Acute Care Setting: A Systematic Review, 2000-2015. Clin Nurs Res. 2018 Jul;27(6):643-659. doi: 10.1177/1054773817705541. Epub 2017 Apr 27.

  PMID: 28447852 RESULT

• Little C, McDonald J, Jenkins MG, McCarron P. An overview of techniques used to measure wound area and volume. J Wound Care. 2009 Jun;18(6):250-3. doi: 10.12968/jowc.2009.18.6.42804.

  PMID: 19661849 RESULT

• Khong PCB, Yeo MSW, Goh CC. Evaluating an iPad app in measuring wound dimension: a pilot study. J Wound Care. 2017 Dec 2;26(12):752-760. doi: 10.12968/jowc.2017.26.12.752.

  PMID: 29244972 RESULT

• Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.

  PMID: 15230830 RESULT

• 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.

  PMID: 33095125 RESULT

• Sahbudak G, Gunes U. Comparing Digital, Mobile and Three-Dimensional Methods in Pressure Injury Measurement: Agreement in Surface Area and Depth Assessments. J Clin Nurs. 2026 Jan;35(1):172-181. doi: 10.1111/jocn.17813. Epub 2025 May 9.

  PMID: 40346762 DERIVED

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant at the Department of Nursing Principles

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: August 12, 2022
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

TU (1)