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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.
Must not have
Any wound likely to require irrigation and debridement in an operating room (OR) setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

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 below
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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.
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My gunshot wound is small and 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a wound that might need cleaning in surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Wound cleansing is a critical step in wound management, involving the removal of debris, exudate, and contaminants to create an optimal environment for healing. Antimicrobial agents in wound cleansers play a vital role by reducing the microbial load on the wound surface, thereby preventing or treating infections that can delay healing. These mechanisms are essential for wound healing patients as they help to minimize complications, reduce healing time, and improve overall outcomes.

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
875 Previous Clinical Trials
329,886 Total Patients Enrolled
1 Trials studying Wound Healing
112 Patients Enrolled for Wound Healing

Media Library

SynEx Wound Cleanser (Wound Cleanser) Clinical Trial Eligibility Overview. Trial Name: NCT05743283 — N/A
Wound Healing Clinical Trial 2023: SynEx Wound Cleanser Highlights & Side Effects. Trial Name: NCT05743283 — N/A
SynEx Wound Cleanser (Wound Cleanser) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743283 — N/A
~46 spots leftby Sep 2025
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