Cleanser for Acute Wounds

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Wound

Intervention / Treatment
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* Device: Antimicrobial Skin & Wound Cleanser (AWC)
* Device: Antimicrobial Wound Gel (AWG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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)<br>* 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.<br>* Other names: AWC;Device: Antimicrobial Wound Gel (AWG)<br>* 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.<br>* Other names: AWG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Wounds, Biofilm, Antimicrobial, Sepsis, Infection, Wound