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Antimicrobial Agent
Antimicrobial Cleanser for Acute Wounds
N/A
Waitlist Available
Led By Rebecca Mcmahon, Masters
Research Sponsored by Rochal Industries LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one wound area must measure equal to or greater than 2cm^2 to include partial or full thickness tears
The wound must be untreated/open beyond bedside stabilization such as irrigation and debridement
Must not have
Patients receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to negatively affect wound healing
Have received more than one dose of antibiotics prior to enrollment or during the study duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effect of a new wound cleanser and gel on 35 people with acute traumatic wounds. It will last 28 days and measure the wound's microbial load.
Who is the study for?
This trial is for adults over 18 with fresh traumatic wounds larger than 4 cm2, who can feel pulses in their limbs or have an acceptable ankle-brachial index. They must be treated at BAMC or listed in the DoDTR and able to understand English. It's not for those with bone exposure, osteomyelitis, on dialysis, pregnant/breastfeeding women, on certain medications affecting wound healing, or unable to consent.
What is being tested?
The study tests a new cleanser and gel on acute wounds to see how they affect wound healing and microbial loads over four weeks. It involves a single group of 35 subjects using both products sequentially without comparing them to other treatments.
What are the potential side effects?
While specific side effects are not detailed here, potential risks may include skin irritation from the cleanser or gel, allergic reactions to ingredients used in the products, and possible interference with natural wound healing processes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a wound that is at least 2cm^2 in size.
Select...
My wound has only been cleaned and possibly had dead tissue removed, but not treated further.
Select...
I am between 18 and 89 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medications that could slow down wound healing.
Select...
I have taken antibiotics more than once before or during the study.
Select...
I am younger than 18 or older than 89.
Select...
I am currently receiving kidney dialysis.
Select...
I have a bone infection known as osteomyelitis.
Select...
I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use effective contraception during the study.
Select...
My wound exposes tendons, ligaments, or bone.
Select...
My wound is smaller than 2 cm squared.
Select...
I have signs of an infected wound or gangrene.
Select...
I am unable to give consent for treatment myself or through a legal representative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Microbial Load
Secondary study objectives
Wound Healing Rates
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Antimicrobial Skin \& Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.
Find a Location
Who is running the clinical trial?
Rochal Industries LLCLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioOTHER
477 Previous Clinical Trials
92,935 Total Patients Enrolled
Brooke Army Medical CenterFED
129 Previous Clinical Trials
27,602 Total Patients Enrolled
MicroGenDXIndustry Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
Rebecca Mcmahon, MastersPrincipal InvestigatorRochal Industires
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that could slow down wound healing.I have taken antibiotics more than once before or during the study.I have a wound that is at least 2cm^2 in size.I am younger than 18 or older than 89.My wound has only been cleaned and possibly had dead tissue removed, but not treated further.I am currently receiving kidney dialysis.My wound is less than 48 hours old.I have a bone infection known as osteomyelitis.My wounds have been closed or repaired.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use effective contraception during the study.I am between 18 and 89 years old.My wound exposes tendons, ligaments, or bone.My wound is older than 48 hours.My wound is smaller than 2 cm squared.I can sign the consent form myself or have someone legally allowed to do it for me.I have signs of an infected wound or gangrene.I am unable to give consent for treatment myself or through a legal representative.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.