Clinical Research Directory

Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds

Sponsor: University of Calgary

Summary

The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds. as measured by recruitment rate, retention, adherence to the assigned treatment schedule, and completeness of outcome data, in each of Study A (CAWL versus standard of care) and Study B (CAWH versus standard of care). The main outcomes it aims to answer are * assessing the impact of treatment on patient-reported health-related quality of life, as measured by the global score and subscores of the validated Wound-QoL questionnaire, from baseline to end of study. * conduct an exploratory within-trial economic evaluation by estimating healthcare resource use, associated costs, and quality-adjusted life years (QALYs) derived from the EQ-5D-5L in the intervention and usual care groups over the study period. * evaluate the safety and tolerability of the investigational products including the incidence, nature, and severity of treatment-emergent adverse events and adverse device reactions. * generate preliminary estimates of clinical effect in each of Study A and Study B, including change in wound surface area from baseline to end of study, change in wound appearance characteristics, and the proportion of participants achieving greater than or equal to 50% reduction in wound surface area Researchers will compare Study A (CAWL) to the control which is the site's routine wound cleansing or irrigation product, selected by the treating clinician as clinically indicated for the wound presentation. This may include an antimicrobial or antiseptic product (e.g., a silver, PHMB, iodine, or honey-based formulation) where clinically appropriate, or a non-antimicrobial solution such as normal saline where it is not. Researchers will compare Study B (CAWH) to the control which is the standard-of-care comparator is the site's routine moisture-donating dressing, selected by the treating clinician as clinically indicated. This may include a dressing with its own antimicrobial barrier claim where clinically appropriate, or a moisture-donation-only dressing where it is not. Participants will in Study A, be given Combatic Lavage (CAWL) as the wound cleansing product. Participants will in Study B, be given Combatic Hydrogel (CAWH) as the wound moisture balancing product.

Official title: Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds: A Multi-Center, Prospective, Open-Label, Randomized Controlled Trial

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