Cleanser for Acute Wounds

NCT05422144 | Withdrawn FDA Device

• 1 other identifier: MTEC-20-02-Multi-Topic-017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Wound

Keywords

Traumatic Wounds; Biofilm; Antimicrobial; Sepsis; Infection; Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound Healing Rates

  28 days

Study Arms (1)

Treatment

EXPERIMENTAL

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); Device: Antimicrobial Wound Gel (AWG)

Interventions

Antimicrobial Skin & Wound Cleanser (AWC) DEVICE

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.

Also known as: BIAKŌS Antimicrobial Skin & Wound Cleanser, AWC

Treatment

Antimicrobial Wound Gel (AWG) DEVICE

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.

Also known as: BIAKŌS Antimicrobial Wound Gel, AWG

Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochal Industries LLC: lead
• Brooke Army Medical Center: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• MicroGenDX: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (21)

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  BACKGROUND

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  PMID: 21074033 BACKGROUND

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  PMID: 11292638 BACKGROUND

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• Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab.

  PMID: 20386331 BACKGROUND

• Raizman R, Dunham D, Lindvere-Teene L, Jones LM, Tapang K, Linden R, Rennie MY. Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection and targeted debridement. J Wound Care. 2019 Dec 2;28(12):824-834. doi: 10.12968/jowc.2019.28.12.824.

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• Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) June 2006 Clinical/Medical. https://www.fda.gov/media/71278/download

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  BACKGROUND

• Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010 Spring;19(1):2-7.

  PMID: 20370999 BACKGROUND

• Geiling J, Rosen JM, Edwards RD. Medical costs of war in 2035: long-term care challenges for veterans of Iraq and Afghanistan. Mil Med. 2012 Nov;177(11):1235-44. doi: 10.7205/milmed-d-12-00031.

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MeSH Terms

Conditions

Sepsis; Infections; Wounds and Injuries

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Mcmahon, Masters

  Rochal Industires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: January 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)