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Cleanser for Acute Wounds

Primary Purpose

Acute Wound

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Antimicrobial Skin & Wound Cleanser (AWC)

Antimicrobial Wound Gel (AWG)

About this trial

This is an interventional treatment trial for Acute Wound focused on measuring Traumatic Wounds, Biofilm, Antimicrobial, Sepsis, Infection, Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients being treated at Brooke Army Medical Center (BAMC) or those identified in the Department of Defense Trauma Registry (DoDTR) with acute traumatic wounds (beneficiary and civilian trauma patients as all have eligibility for follow up post discharge).
Male or female >18
Presence of at least one acute wound with wound area > 4 cm2
Presence of at least one acute wound which includes partial and full thickness skin tears
Adequate arterial perfusion of affected limb, if applicable, defined as at least one of the following: Palpable radial and/or ulnar artery pulse in upper extremity Palpable dorsalis pedis and/or posterior tibial artery pulse in lower extremity Ankle-brachial index (ABI) ≥0.65 if lower extremity pulse weak or nonpalpable
Ability to read/speak English (participant and/ or Legally Authorized Representative (LAR)

Exclusion Criteria:

Suspected or confirmed signs/symptoms of active wound infection or gangrene
Osteomyelitis
Wounds with exposed tendons, ligaments, or bone
Active renal dialysis
Inability for patient or LAR to give consent
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 (such as continuous prednisone), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy, vascular surgery, angioplasty, or thrombolysis
Pregnancy or breastfeeding at time of screening
Participation in another investigational device, drug, or biological trial that may interfere with results within 30 days of screening (subjects will not be rescreened)
Vulnerable populations to include prisoners, children, and pregnant women.
Those unable to consent at baseline (patients with cognitive impairment at baseline such as Alzheimer's/Dementia, Cognitive Disabilities, etc.,)

Sites / Locations

Brooke Army Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Antimicrobial Skin & Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound on a 72-48-48 hr treatment cycle during the 28 day study duration.

Outcomes

Primary Outcome Measures

Microbial Load

As indicated semi-quantitatively by MicroGenDx/ Research and Testing Labs LLC (RTL) swab collection and qualitatively by visual assessments and MolecuLight i:X images.

Secondary Outcome Measures

Wound Healing Rates

% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool

Full Information

NCT ID

NCT05422144

First Posted

June 14, 2022

Last Updated

March 27, 2023

Sponsor

Rochal Industries LLC

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05422144

Brief Title

Cleanser for Acute Wounds

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rochal Industries LLC

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Wound

Keywords

Traumatic Wounds, Biofilm, Antimicrobial, Sepsis, Infection, Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Antimicrobial Skin & Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound on a 72-48-48 hr treatment cycle during the 28 day study duration.

Intervention Type

Device

Intervention Name(s)

Antimicrobial Skin & Wound Cleanser (AWC)

Other Intervention Name(s)

BIAKŌS Antimicrobial Skin & Wound Cleanser, AWC

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Antimicrobial Wound Gel (AWG)

Other Intervention Name(s)

BIAKŌS Antimicrobial Wound Gel, AWG

Intervention Description

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.

Primary Outcome Measure Information:

Title

Microbial Load

Description

As indicated semi-quantitatively by MicroGenDx/ Research and Testing Labs LLC (RTL) swab collection and qualitatively by visual assessments and MolecuLight i:X images.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Wound Healing Rates

Description

% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients being treated at Brooke Army Medical Center (BAMC) or those identified in the Department of Defense Trauma Registry (DoDTR) with acute traumatic wounds (beneficiary and civilian trauma patients as all have eligibility for follow up post discharge). Male or female >18 Presence of at least one acute wound with wound area > 4 cm2 Presence of at least one acute wound which includes partial and full thickness skin tears Adequate arterial perfusion of affected limb, if applicable, defined as at least one of the following: Palpable radial and/or ulnar artery pulse in upper extremity Palpable dorsalis pedis and/or posterior tibial artery pulse in lower extremity Ankle-brachial index (ABI) ≥0.65 if lower extremity pulse weak or nonpalpable Ability to read/speak English (participant and/ or Legally Authorized Representative (LAR) Exclusion Criteria: Suspected or confirmed signs/symptoms of active wound infection or gangrene Osteomyelitis Wounds with exposed tendons, ligaments, or bone Active renal dialysis Inability for patient or LAR to give consent 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 (such as continuous prednisone), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy, vascular surgery, angioplasty, or thrombolysis Pregnancy or breastfeeding at time of screening Participation in another investigational device, drug, or biological trial that may interfere with results within 30 days of screening (subjects will not be rescreened) Vulnerable populations to include prisoners, children, and pregnant women. Those unable to consent at baseline (patients with cognitive impairment at baseline such as Alzheimer's/Dementia, Cognitive Disabilities, etc.,)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlyn Abbott

Phone

2103759349

Cabbott@rochaltech.com

First Name & Middle Initial & Last Name or Official Title & Degree

Cindy Taylor

Phone

2103759349

cstaylor@rochaltech.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Mcmahon, Masters

Organizational Affiliation

Rochal Industires

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brooke Army Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlyn M Abbott, BS

Phone

210-375-9349

cabbott@rochaltech.com

First Name & Middle Initial & Last Name & Degree

Julie A Rizzo

First Name & Middle Initial & Last Name & Degree

Remealle How

First Name & Middle Initial & Last Name & Degree

Phillip Kempbohan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

Citation

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Results Reference

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PubMed Identifier

21074033

Citation

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Citation

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Citation

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Cleanser for Acute Wounds

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