Cleanser for Acute Wounds

Acute Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05422144
• Other study ID #: MTEC-20-02-Multi-Topic-017
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Rochal Industries LLC
• Contact: Carlyn Abbott
• Phone: 2103759349
• Email: Cabbott[@]rochaltech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Wound
• Wounds and Injuries

Intervention

Device:
• Antimicrobial Skin & Wound Cleanser (AWC)
BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site. BIAKOS™ 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)
BIAKOS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKOS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial polyhexamethylene biguanide (PHMB). BIAKOS 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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Rochal Industries LLC	Brooke Army Medical Center, MicroGenDX, The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (21)

Army, O. of T. S. G. U. S. Infections. Emergency War Surgery, Fourth United States Revision (2013).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Jennison, C. & Turnbull, B., Group Sequential Methods with Applications to Clinical Trials. (Chapman & Hall/CRC, 2000).

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schultz JR, Nichol FR, Elfring GL, Weed SD. Multiple-stage procedures for drug screening. Biometrics. 1973 Jun;29(2):293-300. No abstract available. — View Citation

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. — View Citation

Stewart, L. et al. Combat-Related Extremity Wound Infection Epidemiology: Trauma Infectious Disease Outcomes Study 2009-2012. Open Forum Infect. Dis. 2, (2015).

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound Healing Rates	% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool	28 days