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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
73
Nursing staff include the use of ACE in their routine clinical practice to support their chronic wound treatment decision-making process.
Professionals in the non-ACE group will carry out their usual clinical practice of chronic wound care.
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, Spain
Treatment group
ACE or non-ACE
Time frame: Day 0
Health center
Open Field
Time frame: Day 0
Training of healthcare professionals
Academic training of healthcare professionals
Time frame: Day 0, at the start of the professional's participation
Years of experience of healthcare professionals
Years of experience of healthcare professionals in healing chronic wounds
Time frame: Day 0, at the start of the professional's participation
SUS
Score obtained after completing the System Usability Scale questionnaire
Time frame: At month 1, month 3 and month 5 after the professional's participation
NASA TLX
Score obtained after completing the NASA TLX questionnaire
Time frame: At month 1, month 3 and month 5 after the professional's participation
Patient age
Patient's age in years
Time frame: Day 0, at the start of recruitment
Gender
Male or female
Time frame: Day 0, at the start of recruitment
Diseases
Indicate, if applicable, the following option(s): DM I or II, venous and/or arterial insufficiency, ischemia, obesity, osteomyelitis, diabetic neuropathy, others.
Time frame: Day 0, at the start of recruitment
Allergies
Open field
Time frame: Day 0, at the start of recruitment
Recurrent medication
Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.
Time frame: Day 0, at the start of recruitment
History of chronic wounds
Indicate, if applicable, etiology, highest classification, location, and if healed, the approximate closing date.
Time frame: Day 0, at the start of recruitment
Number of wounds in the same patient
Number
Time frame: Day 0 and follow-up day every 2 weeks until end of recruitment
Wound location
Open field
Time frame: Day 0, at the start of recruitment
Date of first consultation
Date
Time frame: Day 0, at the start of recruitment
Date of wound closure
Date
Time frame: Day of wound closure after follow-up
Date of loss to follow-up (if applicable)
Date
Time frame: Day of loss to follow-up after follow-up
Reason of loss to follow-up (if applicable)
Open field
Time frame: Day of loss to follow-up after follow-up
Date of treatment decision
Date
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Use of ACE?
Yes or No
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Wound size
Width, length and depth (if applicable) measured in cm
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Tissues in the wound bed
Indicate the following option(s): Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Dominant tissue in the wound bed
Select one of the options: Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Exudate level
Select one of the options: 0 none, 1 scarce, 2 moderate, 3 abundant
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Condition of the perilesional skin
Indicate the following option(s): Macerated, Erythema or inflammation, Eczema, Fragile skin
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Etiology of the wound
Select one of the options: LESCAH, Diabetic foot, Burn, Arterial, Pressure, Venous, Not determined
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Category of the wound
Indicate the corresponding one according to the selected etiology: LESCAH: 1A/1B/2A/2B; Diabetic foot (Wagner): I/II/III/IV/V; Burn: 1st/2nd/2nd deep/3rd; Arterial: hypertensive ulcer (of Martorell)/arteriosclerotic ulcer/angitic ulcer (of Buerger); Pressure: I/II/III/IV; Venous: C2 (varicose veins)/C3 (edema)/C4a (pigmentation and/or eczema)/C4b (lipodermatosclerosis or white atrophy)/C5 (healed ulceration)/C6 (active ulceration).
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Applied products
Indicate the following option(s): Actisorb plus 25, Allevyn Adhesive 12, Allevyn Gentle Border 7, Allevyn Heel 13, Allevyn Sacrum 22 x 22 cm, Aquacel Ag, Aquacel Ag + Extra, Aquacel Ag Tape, Aquacel Ag Foam, Aquacel tape, Aquacel Extra, Adhesive Aquacel Foam, Non-Adhesive Aquacel Foam, Aquacel foam pro, Askina carbosorb, Biatain Contact, Biatain non adhesive, Biatain, Silicone with border, Biatain Silicone Without Rim, Cavilon, Comfeel plus sacral, Comfeel plus transparent, Convamax Superabsorb, Conveen Protact, Corpitol, Topical corticosteroid, Cutimed Alginate, Cutimed Sorbact, Cutmed Epiona, Non-sterile Granudacyn, Transparent Hydrotac, Intrasite gel, Iodosorb, Iruxol, Mepilex Border Flex Lite, Mepilex border flex oval, Mepilex border sacrum, Microdacyn 60 Sterile, Trionic, Urgo K2, Urgoclean, Urgoclean AG, Urgostart Plus Pad, Urgotul, Urgotul AG, Varihesive Extra Fine, Varihesive Gel Control, Vliwaktiv AG, Others.
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Date of Adverse Event (if applicable)
Date
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Adverse Event classification (if applicable)
Indicate the following option(s): Severe, Not severe, Expected, Unexpected, Related, Possibly related, Not related
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Description of Adverse Event (if applicable)
Open field describing the event, device deficiency (if applicable), clinical signs, clinical impact, patient action/treatment/outcome.
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Measure taken after Adverse Event (if applicable)
Select one of the options: None, Change of treatment, Other.
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Outcome of the Adverse Event (if applicable)
Select one of the options: Recovered, Recovering, Not recovered, Recovered with sequelae, Fatal, Unknown
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Date of resolution of the Adverse Event (if applicable)
Date
Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
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