Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers

NAUnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

May 1, 2023

Study Completion Date

May 25, 2023

Conditions
Wound of Skin
Interventions
DEVICE

Normal Saline and Amorphous gel

Saline - sodium chloride and water Amorphous hydrogel dressings are formulations of water, polymers

DEVICE

BIAKOS™ Antimicrobial Skin & Wound Cleanser, BIAKŌS Antimicrobial Wound Gel

"Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site.~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 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."

Trial Locations (1)

78701

The Serens Group Austin Research Center, Austin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanara MedTech

UNKNOWN

lead

SerenaGroup, Inc.

NETWORK