Cleanser for Acute Wounds

November 29, 2023 updated by: Rochal Industries LLC

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Julie A Rizzo
        • Sub-Investigator:
          • Remealle How
        • Sub-Investigator:
          • Phillip Kempbohan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 18 to 89 years old.
  • Patients receiving care in the ED/trauma bay or admitted to Brooke Army Medical Center (BAMC) from the ED or trauma bay.
  • At least one wound area must measure equal to or greater than 2cm^2 to include partial or full thickness tears.
  • Wound sustained less than 48-hours from time of enrollment.
  • The wound must be untreated/open beyond bedside stabilization such as irrigation and debridement (i.e., no stitches, steristrips, dermabond, OR washouts, etc).
  • Capable of providing informed written consent by self or through Legally Authorized Representative (LAR).
  • Ability to read/speak English (participant and/ or LAR).

Exclusion Criteria:

  • Ages less than 18 or greater than 89 years old.
  • Patients not receiving care in the ED/trauma bay or admitted to BAMC through the ED or trauma bay.
  • Wound area less than 2 cm2.
  • Wound sustained greater than 48-hours from the time of enrollment.
  • Wounds that have been closed/repaired at the time of screening (i.e. stitches, steristrips, dermabond, washouts in the OR, etc.) or anytime during the study duration.
  • Not capable of providing informed written consent by self or through LAR.
  • Non-English reading and speaking (participant and/or LAR).
  • Have received more than one dose of antibiotics prior to enrollment or during the study duration.
  • Suspected or confirmed signs/symptoms of active wound infection or gangrene.
  • Patients with osteomyelitis.
  • Wounds with exposed tendons, ligaments, or bone.
  • Patients undergoing active renal dialysis.
  • Patients receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to negatively affect wound healing such as systemic steroids (i.e. continuous prednisone), immunosuppressive therapy, chemotherapy, autoimmune disease therapy, cytostatic therapy, vascular surgery, angioplasty, or thrombolysis.
  • Pregnant, breastfeeding, or women of childbearing potential who do not agree to use an effective form of contraception during their participation in the study.
  • Participation in another investigational device, drug, or biological trial that may interfere with results within 30 days of screening.
  • Anyone deemed by the PI to be unlikely to comply with all study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Antimicrobial Skin & Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.
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.
Other Names:
  • BIAKŌS Antimicrobial Skin & Wound Cleanser
  • AWC
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.
Other Names:
  • BIAKŌS Antimicrobial Wound Gel
  • AWG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial Load
Time Frame: 28 days
As indicated semi-quantitatively by MicroGenDx/ Research and Testing Labs LLC (RTL) swab collection and qualitatively by visual assessments and MolecuLight i:X images.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing Rates
Time Frame: 28 days
% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochal Industries LLC

Collaborators

The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
MicroGenDX

Investigators

  • Principal Investigator: Rebecca Mcmahon, Masters, Rochal Industires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTEC-20-02-Multi-Topic-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data collected for this study will remain within the access of the study team and collaborators only. The same study team will utilize this data to compare with a retrospective study to serve as the control comparison for this study. This data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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