Clinical trial NCT05422144: Cleanser for Acute Wounds
Official title: BIAKOS Antimicrobial Wound Cleanser and BIAKOS Antimicrobial Wound Gel: Providing Biofilm Prevention and Treatment Through Continuum of Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Wound
Keywords: Traumatic Wounds
Biofilm
Antimicrobial
Sepsis
Infection
Wound
Lead sponsor: Rochal Industries LLC
Sponsor class: INDUSTRY
Collaborators: name: Brooke Army Medical Center
name: The University of Texas Health Science Center at San Antonio
name: MicroGenDX
First posted: 2022-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Microbial Load
timeFrame: 28 days
Secondary outcomes:
measure: Wound Healing Rates
timeFrame: 28 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Rochal Industires
name: Rebecca Mcmahon, Masters
role: PRINCIPAL_INVESTIGATOR
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