Status:
WITHDRAWN
Cleanser for Acute Wounds
Lead Sponsor:
Rochal Industries LLC
Collaborating Sponsors:
Brooke Army Medical Center
The University of Texas Health Science Center at San Antonio
Conditions:
Acute Wound
Eligibility:
All Genders
18-89 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05422144
Start Date
January 1 2024
End Date
April 30 2025
Last Update
May 4 2025
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234