Cleanser for Acute Wounds

Not Applicable

Withdrawn

• Conditions: Acute Wound
• Interventions: Device: Antimicrobial Skin & Wound Cleanser (AWC); Device: Antimicrobial Wound Gel (AWG)

• Registration Number: NCT05422144
• Lead Sponsor: Rochal Industries LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Study Start: 2024-01-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	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.
Treatment	Antimicrobial Skin & Wound Cleanser (AWC)	Antimicrobial Skin \& Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.

Primary Outcome Measures

Name	Time	Method
Microbial Load	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.

Secondary Outcome Measures

Name	Time	Method
Wound Healing Rates	28 days	% reduction in wound bed size over time as determined by wound measurement and Bates-Jensen Wound Assessment Tool

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States