NCT05422144

Cleanser for Acute Wounds

BIAKOS Antimicrobial Wound Cleanser and BIAKOS Antimicrobial Wound Gel: Providing Biofilm Prevention and Treatment Through Continuum of Care

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rochal Industries LLC · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will be a prospective trial of management of acute traumatic wounds (less than 24 hours from injury and without previous intervention aside from a dressing for coverage). The study design involves a prospective single arm, 35 subject study that analyzes the effect of the subsequent application of a novel wound cleanser and wound gel on subjects' acute traumatic wounds and the respective microbial loads over a 28 day study duration.

Conditions

• Acute Wound

Interventions

Type	Name	Description
DEVICE	Antimicrobial Skin & Wound Cleanser (AWC)	BIAKŌS™ Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site. BIAKŌS™ Antimicrobial Skin and Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The preservative, polyhexamethylene biguanide (PHMB), at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA). and fungus Candida albicans within the product.
DEVICE	Antimicrobial Wound Gel (AWG)	BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial polyhexamethylene biguanide (PHMB). BIAKŌS Antimicrobial Wound Gel: * Resists microbial colonization within the gel during shelf storage. * Provides an amorphous gel covering. * Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement in which the body's own enzymes breakdown necrotic tissue.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-06-16
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study