Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
Study NCT ID:
NCT05107050
Status:
UNKNOWN
Last Update Posted:
2023-04-26
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
SerenaGroup, Inc.
Organization:
Study Overview
Official Title:
A Randomized Double-blind Controlled Clinical Trial 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
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a randomized double-blind controlled clinical trial designed to compare healing rates between normal saline wash in combination with an amorphous gel (NSS-HG) versus the grouping of a synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG) in chronic lower extremity ulcers.
After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed saline wash and an amorphous gel (NSS-HG) or synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG). After cleansing the wound a second MiX is performed. The subject is given a four-week supply.
After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed saline wash and an amorphous gel (NSS-HG) or synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG). After cleansing the wound a second MiX is performed. The subject is given a four-week supply.
Detailed Description:
BIAKOS™ Antimicrobial Skin \& Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site. BIAKOS™ Antimicrobial Skin and Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The preservative, 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: