Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-01-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Antimicrobial Skin \& Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
89 Years
ALL
No
Sponsors
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Brooke Army Medical Center
FED
The University of Texas Health Science Center at San Antonio
OTHER
MicroGenDX
INDUSTRY
Rochal Industries LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Mcmahon, Masters
Role: PRINCIPAL_INVESTIGATOR
Rochal Industires
Locations
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Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Countries
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References
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Army, O. of T. S. G. U. S. Infections. Emergency War Surgery, Fourth United States Revision (2013).
Black CE, Costerton JW. Current concepts regarding the effect of wound microbial ecology and biofilms on wound healing. Surg Clin North Am. 2010 Dec;90(6):1147-60. doi: 10.1016/j.suc.2010.08.009.
Bowler PG, Duerden BI, Armstrong DG. Wound microbiology and associated approaches to wound management. Clin Microbiol Rev. 2001 Apr;14(2):244-69. doi: 10.1128/CMR.14.2.244-269.2001.
Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
Percival SL, Hill KE, Williams DW, Hooper SJ, Thomas DW, Costerton JW. A review of the scientific evidence for biofilms in wounds. Wound Repair Regen. 2012 Sep-Oct;20(5):647-57. doi: 10.1111/j.1524-475X.2012.00836.x.
Donlan RM, Costerton JW. Biofilms: survival mechanisms of clinically relevant microorganisms. Clin Microbiol Rev. 2002 Apr;15(2):167-93. doi: 10.1128/CMR.15.2.167-193.2002.
Hoiby N, Bjarnsholt T, Givskov M, Molin S, Ciofu O. Antibiotic resistance of bacterial biofilms. Int J Antimicrob Agents. 2010 Apr;35(4):322-32. doi: 10.1016/j.ijantimicag.2009.12.011. Epub 2010 Feb 10.
Leid JG, Willson CJ, Shirtliff ME, Hassett DJ, Parsek MR, Jeffers AK. The exopolysaccharide alginate protects Pseudomonas aeruginosa biofilm bacteria from IFN-gamma-mediated macrophage killing. J Immunol. 2005 Dec 1;175(11):7512-8. doi: 10.4049/jimmunol.175.11.7512.
Stewart PS, Costerton JW. Antibiotic resistance of bacteria in biofilms. Lancet. 2001 Jul 14;358(9276):135-8. doi: 10.1016/s0140-6736(01)05321-1.
Gutierrez D, Hidalgo-Cantabrana C, Rodriguez A, Garcia P, Ruas-Madiedo P. Monitoring in Real Time the Formation and Removal of Biofilms from Clinical Related Pathogens Using an Impedance-Based Technology. PLoS One. 2016 Oct 3;11(10):e0163966. doi: 10.1371/journal.pone.0163966. eCollection 2016.
Wolcott RD, Rhoads DD, Bennett ME, Wolcott BM, Gogokhia L, Costerton JW, Dowd SE. Chronic wounds and the medical biofilm paradigm. J Wound Care. 2010 Feb;19(2):45-6, 48-50, 52-3. doi: 10.12968/jowc.2010.19.2.46966.
Rasmussen TE, Baer DG, Remick KN, Ludwig GV. Combat casualty care research for the multidomain battlefield. J Trauma Acute Care Surg. 2017 Jul;83(1 Suppl 1):S1-S3. doi: 10.1097/TA.0000000000001469. No abstract available.
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.
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.
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
Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
Schultz JR, Nichol FR, Elfring GL, Weed SD. Multiple-stage procedures for drug screening. Biometrics. 1973 Jun;29(2):293-300. No abstract available.
Jennison, C. & Turnbull, B., Group Sequential Methods with Applications to Clinical Trials. (Chapman & Hall/CRC, 2000).
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.
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.
Mende K, Stewart L, Shaikh F, Bradley W, Lu D, Krauss MR, Greenberg L, Yu Q, Blyth DM, Whitman TJ, Petfield JL, Tribble DR. Microbiology of combat-related extremity wounds: Trauma Infectious Disease Outcomes Study. Diagn Microbiol Infect Dis. 2019 Jun;94(2):173-179. doi: 10.1016/j.diagmicrobio.2018.12.008. Epub 2018 Dec 29.
Other Identifiers
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MTEC-20-02-Multi-Topic-017
Identifier Type: -
Identifier Source: org_study_id
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