This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species. This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.
The central aim of this study is to investigate the safety, tolerability, and indicative efficacy of a single dose of a phage therapy combination product, BACTELIDE, as an adjunct to standard therapy in participants presenting with a Stage II, III or IV pressure injuries with positive wound cultures for S. aureus, P. aeruginosa, or K. pneumoniae at screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages encapsulated in a biodegradable polymer. This bacteriophage product will be delivered topically every 3 days for 56 days or until wound has healed.
Placebo intervention consists of a dosage-metered airless spray containing a buffer solution analogous to the study intervention. This placebo will be delivered topically every 3 days for 56 days or until wound has healed.
Standard of care consists of but is not limited to offloading, positioning, cleansing, debridement, and wound dressing. A topical antimicrobial hydrogel will applied to wounds with signs of localized infection.
Incidence of Treatment-Emergent Adverse Events coded by MedDra
Safety of BACTELIDE will be measured by the number and percent of treatment related adverse events.
Time frame: At least 56 days
Incidence of treatment discontinuation due to adverse events
Tolerability of BACTELIDE will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events
Time frame: 56 days
Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.
Response/improvement in treatment-specific clinical outcome based on change in PUSH tool scores.
Time frame: 28 days
Assess the effect of BACTELIDE on the incidence of bacterial colonization by S. aureus, P. aeruginosa, or K. pneumoniae species in pressure injury wounds.
Change in the incidence of positive wound cultures for S. aureus, P. aeruginosa, K. pneumoniae collected from surface deep wound swabs and /or tissue specimens.
Time frame: 28 days
Assess the effect of BACTELIDE on the rate of wound progression.
Rate of wound progression will be measured by change in viable tissue.
Time frame: 56 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.