Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact

Fundacin Biomedica Galicia Sur

Status: Completed

Conditions: Wound Complication; Wounds and Injuries

Treatments: Other: Control (non-ACE); Device: Advanced Cutaneous Evaluator (ACE)

Study type: Interventional

Funder types: Other

Identifiers

NCT07275385

ACE

Details and patient eligibility

About

ACE is a clinical decision support system for selecting appropriate products for the local treatment of chronic wounds. It was designed with a user-centered approach, and its usability and feasibility have been previously validated in pilot studies with nurses. This protocol will allow for the clinical validation of the software in 18 primary care centers, including the quantification of the clinical and economic effects of using the tool over 9 months. It is a mixed-methods design that includes a randomized controlled trial in which nursing staff incorporate the use of ACE into their routine clinical practice to support their decision-making process for chronic wound treatment. It also includes a usability evaluation throughout the study.

Full description

To estimate the clinical and economic impact of ACE, wounds will be reviewed at baseline and every two weeks until closure or until the end of the study period. Wound size will be recorded, and whether or not the wound is closed will be noted, with a maximum follow-up period of 16 weeks. A follow-up will be conducted four weeks after wound closure to assess wound dehiscence or other adverse events. Given these wound follow-up periods, only wounds incurred during the first three months of the study, after the completion of professional recruitment and training, will be included for those assigned to the ACE group. A longitudinal study will be conducted in 18 primary care centers in Galicia.

Once the study period is complete, the clinical and economic impact will be evaluated by comparing the following indicators between the two groups: the primary outcome will be wound closure, and secondary outcomes will include wound evolution (including its size every two weeks from the first ulcer assessment and wound bed tissue assessment), length of hospital stay, readmissions, incidence of hospital-acquired injuries, and the cost of products used for wound treatment. Comparative analyses will be performed by subdividing the groups according to the users' experience in chronic wound treatment at the start of the study and according to the type of chronic wound. In addition, instances in which users in the ACE group choose not to follow the application's recommendations will be recorded and quantified.

To evaluate the usability and acceptability of ACE by nursing staff, validated quantitative and standardized tools will be used. Only professionals assigned to the ACE group will participate, using ACE as a decision support tool whenever they need to select products for wound treatment. On one day during the second week of months 2, 4, and 6, the usability and acceptance of the application will be evaluated by the professionals assigned to the ACE group using the System Usability Scale (SUS). Simultaneously, the NASA TLX scale, which quantifies mental workload as an aspect of usability, will be evaluated in both groups.

Enrollment: 73 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthcare professionals responsible for selecting products for the local treatment of chronic, curable wounds in adult patients.
• Patients with chronic wounds, aged 18 to 100 years.
• Patients with wounds healing by secondary intention, aged 18 to 100 years.
• Patients and/or professionals who have signed the informed consent form for the study.

Exclusion criteria

• Minors
• Wounds of patients with acute surgical wounds, aged between 18 and 100 years.
• Images containing features that allow patient identification, such as tattoos and/or moles, or where part of the face is visible.
• Wounds corresponding to third-degree burns, tumor wounds, ischemic ulcers, pyoderma gangrenosum, and ulcers with osteomyelitis without systemic antibiotic treatment.
• Patients and professionals who declined to participate after reading the report Informed Consent Form.

Exclusion criteria:

• During the study, exclusion criteria include wounds lost to follow-up before completing 4 weeks of treatment, except for those that complete follow-up due to wound healing and discharge. Additionally, healthcare professionals and patients who withdraw their consent and wish to leave the study will be excluded.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

control (non-ACE)

Active Comparator group

Description:

professionals in the non-ACE group will carry out their usual clinical practice of healing chronic wounds and, in the same way as members of the ACE group, each time they make a decision about local treatment products for these wounds, they must record it in the data collection notebook.

Treatment:

Other: Control (non-ACE)

ACE

Experimental group

Description:

The professionals assigned to the ACE group will recruit patients whose wounds will be photographed for use in the application. These images will not be saved but will be deleted immediately after each treatment consultation using the ACE application. Clinical judgment will always prevail. If the professional considers the treatments suggested by ACE unsuitable, they will not apply any of them; instead, they will treat the patient with what they deem best as a healthcare professional. For the purposes of this study, the healthcare professionals in the experimental group will use the software as a clinical decision support system to consult the products they recommend for wound treatment, recommending only wound care products commonly used in participating centers.

Treatment:

Device: Advanced Cutaneous Evaluator (ACE)