NanoSALV vs Standard Topical Care Pathway in Sports-Related Skin Lesions

You may not qualify if:

• Known Allergies or Sensitivities to Study Interventions: Individuals with a known allergy to any active or inactive ingredients utilized in either treatment arm, including bacitracin, polymyxin B, gramicidin, petrolatum, or copper-based compounds.
• Justification: This is a primary safety measure to prevent severe allergic contact dermatitis or systemic hypersensitivity reactions. To maintain the double-blinded integrity of the study, the screening process will not ask participants about specific brand names directly. Instead, participants will be screened using a consolidated list of specific ingredients present across all products to ensure potential allergens are avoided without revealing the exact nature of the interventions.
• Underlying Medical Conditions Affecting Wound Healing: Individuals with systemic conditions known to impair tissue repair or alter skin integrity, such as diabetes mellitus, peripheral vascular disease, or autoimmune disorders.
• Justification: These conditions inherently alter physiological healing timelines and subjective sensory perception (e.g., peripheral neuropathy). Excluding these individuals controls for significant confounding variables, ensuring that any statistical differences in healing time can be directly attributed to the topical interventions.
• Pre-existing Severe Infection of the Target Lesion: Participants presenting with friction blisters that already exhibit clinical signs of severe or systemic infection, such as excessive purulent discharge, spreading erythema, or red streaking, prior to group assignment.
• Justification: Wounds with severe pre-existing infections require immediate standard medical care, such as oral antibiotics. Including these lesions would compromise participant safety and skew the baseline healing trajectory compared to standard, acute friction blisters.
• Concurrent Use of Alternative Wound Treatments: Individuals currently utilizing other topical antibiotics, corticosteroid creams, or systemic immunosuppressive medications.
• Justification: The concurrent use of active pharmacological agents introduces confounding treatment effects. This would make it scientifically impossible to isolate the primary main effect of NanoSALV Catalytic or the Standard Topical Care Pathway on the wound area.
• Presence of Acute or Severe Musculoskeletal Injuries: Individuals who sustained major acute injuries during the ultra-distance event.
• Justification: Secondary trauma alters systemic inflammatory responses and subjective pain perception. This systemic noise complicates the localized subjective assessments, such as the Visual Analog Scale (VAS) for pain perception.
• Pregnancy or Breastfeeding: Individuals who are pregnant or breastfeeding.
• Justification: This is a contraindicated population for the standard, over-the-counter components utilized in the Standard Topical Care Pathway.
• Blood Blisters: Lesions that are blood blisters rather than clear friction blisters are not eligible to serve as the index lesion.
• Justification: Blood blisters involve dermal vessel injury and follow a different physiological healing trajectory. Including them would introduce heterogeneity into the primary outcome.