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Wound Cleanser
SynEx Wound Rinse for Traumatic Wounds
N/A
Recruiting
Led By Shenda Baker, PhD
Research Sponsored by Synedgen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Penetrating, puncture or laceration wounds: stage II-III (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle.
Gunshot wounds (GSW): Grade I - II on the Red Cross Classification of War Wounds6 (diameter of entry + exit wounds < 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). Non-penetrating, penetrating, or perforated GSW are included. GSW with suspected vascular injuries or nerve damage are excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study Summary
This trial looks at how an experimental wound cleanser affects healing in traumatic wounds. Participants attend up to 4 visits & use the assigned cleanser. Surveys measure healing & well-being.
Who is the study for?
Adults with certain types of wounds—like gunshot, penetrating, or burn wounds—but not diabetic ulcers or severe injuries needing surgery. Participants must be over 18, able to use a computer or mobile for virtual visits, and willing to follow the study's procedures.Check my eligibility
What is being tested?
The trial is testing SynEx Wound Cleanser against routine saline treatment in people with traumatic wounds. It involves up to four visits where participants will use their assigned cleanser and report on their healing process.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to wound cleansing such as skin irritation, allergic reactions if sensitive to ingredients in SynEx, or discomfort during application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My wound is a deep cut or puncture that does not show bone or muscle.
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My gunshot wound is minor to moderate without major bone or nerve damage.
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I have burns covering 9% or less of my body, not caused by radiation or frostbite.
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I have a recent sharp, puncture, or burn injury on my arm or leg that fits the study's criteria.
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My wound is a deep cut or puncture that does not show bone or muscle and is not due to diabetes, poor vein health, or pressure.
Select...
My gunshot wound is small and without major bone or nerve damage.
Select...
I have burns covering 9% or less of my body, not caused by radiation or frostbite.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound healing environment composite score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SynExExperimental Treatment1 Intervention
The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.
Group II: SalineActive Control1 Intervention
The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.
Find a Location
Who is running the clinical trial?
Medical Technology Enterprise ConsortiumUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Synedgen, Inc.Lead Sponsor
2 Previous Clinical Trials
141 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,094 Total Patients Enrolled
1 Trials studying Wound Healing
112 Patients Enrolled for Wound Healing
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been more than 72 hours since my injury occurred.My gunshot wound is small and without major bone or nerve damage.My wound is a deep cut or puncture that does not show bone or muscle.I have burns covering 9% or less of my body, not caused by radiation or frostbite.I am 18 years old or older.I have a recent sharp or burn injury on my arm or leg that fits the study's criteria.I have a wound that might need cleaning in surgery.I have other serious injuries or conditions along with my skin injury.I have a recent sharp, puncture, or burn injury on my arm or leg that fits the study's criteria.My wound is a deep cut or puncture that does not show bone or muscle and is not due to diabetes, poor vein health, or pressure.I have burns covering 9% or less of my body, not caused by radiation or frostbite.I am 18 years old or older.My gunshot wound is minor to moderate without major bone or nerve damage.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study currently recruiting participants?
"The analysis available on clinicaltrials.gov affirms that this trial is not currently accepting participants, as it was posted in March of 2023 and last updated February 14th of the same year. Nevertheless, there are 772 other trials actively recruiting individuals right now."
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