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Cleanser for Acute Wounds

NCT05422144 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Brooke Army Medical Center

    collaborator FED

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • MicroGenDX

    collaborator INDUSTRY

  • Rochal Industries LLC

    lead INDUSTRY

Principal Investigators

  • Rebecca Mcmahon, Masters · Rochal Industires

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422144 on ClinicalTrials.gov