Acute WoundNCT05422144
Cleanser for Acute Wounds
A study testing Antimicrobial Skin & Wound Cleanser (AWC) and Antimicrobial Wound Gel (AWG) in people with Acute Wound, run by Rochal Industries LLC at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Wound
- What is being tested?
- Antimicrobial Skin & Wound Cleanser (AWC) and Antimicrobial Wound Gel (AWG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: BIAKOS Antimicrobial Wound Cleanser and BIAKOS Antimicrobial Wound Gel: Providing Biofilm Prevention and Treatment Through Continuum of Care
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
- Being tested
- Antimicrobial Skin & Wound Cleanser (AWC), Antimicrobial Wound Gel (AWG)
- Keywords
- Traumatic Wounds, Biofilm, Antimicrobial, Sepsis, Infection, Wound
- Medical subject headings
- Sepsis, Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Skin & Wound Cleanser (AWC)Device
Also called BIAKŌS 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)Device
Also called BIAKŌS 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Antimicrobial Skin \& Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration. Receives: Device: Antimicrobial Skin & Wound Cleanser (AWC); Device: Antimicrobial Wound Gel (AWG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Wound Healing Rates
% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jan 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: That aim was forfeited due to enrollment challenges and lack of remaining funding to accomplish.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Acute WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochal Industries LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brooke Army Medical Center, The University of Texas Health Science Center at San Antonio, MicroGenDX
- Responsible party
- Sponsor
- Investigators
- Rebecca Mcmahon, Masters, Principal investigator, Rochal Industires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422144
- Sponsor's protocol ID
- MTEC-20-02-Multi-Topic-017
- Status last verified
- Apr 2025
- First submitted
- 14 Jun 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21074033Bowler 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.
PubMed 11292638Church 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.
PubMed 16614255Percival 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.
PubMed 22985037Donlan 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.
PubMed 11932229Hoiby 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.
PubMed 20149602Leid 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.
PubMed 16301659Stewart 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.
PubMed 11463434Gutierrez 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.
PubMed 27695058Wolcott 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.
PubMed 20216488Rasmussen 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.
PubMed 28628599Harris 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.
PubMed 20386331Raizman 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.
PubMed 31825778Guidance 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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIAKOS Antimicrobial Wound Cleanser and BIAKOS Antimicrobial Wound Gel: Providing Biofilm Prevention and Treatment Through Continuum of Care
- ClinicalTrials.gov ID
- NCT05422144
- Acronym / sponsor ID
- MTEC-20-02-Multi-Topic-017
- Conditions
- Acute Wound
- Keywords
- Traumatic Wounds, Biofilm, Antimicrobial, Sepsis, Infection, Wound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: That aim was forfeited due to enrollment challenges and lack of remaining funding to accomplish.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rochal Industries LLCIndustry (pharma, biotech, devices)
- Collaborators
- Brooke Army Medical Center, The University of Texas Health Science Center at San Antonio, MicroGenDX
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Antimicrobial Skin & Wound Cleanser (AWC), Device: Antimicrobial Wound Gel (AWG)Antimicrobial Skin \& Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial Skin & Wound Cleanser (AWC)Also: BIAKŌS Antimicrobial Skin & Wound Cleanser, AWCBIAKŌS™ 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. | Device | Treatment |
| Antimicrobial Wound Gel (AWG)Also: BIAKŌS Antimicrobial Wound Gel, AWGBIAKŌS 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. | Device | Treatment |
Primary outcome
Microbial Load
Time frame: 28 days
As indicated semi-quantitatively by MicroGenDx/ Research and Testing Labs LLC (RTL) swab collection and qualitatively by visual assessments and MolecuLight i:X images.
1 secondary outcome
Wound Healing Rates
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- BackgroundArmy, O. of T. S. G. U. S. Infections. Emergency War Surgery, Fourth United States Revision (2013).
- Background: PubMed 21074033Black 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.
- Background: PubMed 11292638Bowler 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.
- Background: PubMed 16614255Church 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.
- Background: PubMed 22985037Percival 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.
- Background: PubMed 11932229Donlan 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.
- Background: PubMed 20149602Hoiby 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.
- Background: PubMed 16301659Leid 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.
- Background: PubMed 11463434Stewart 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.
- Background: PubMed 27695058Gutierrez 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.
- Background: PubMed 20216488Wolcott 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.
- Background: PubMed 28628599Rasmussen 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Mcmahon, Masters principal investigator
Rochal Industires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial Skin & Wound Cleanser (AWC) and Antimicrobial Wound Gel (AWG) in people with Acute Wound, run by Rochal Industries LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Load (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422144, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.