NCT05743283 Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
| NCT ID | NCT05743283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Synedgen, Inc. |
| Condition | Wound Heal |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-12 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.
Eligibility Criteria
Inclusion Criteria: 1. Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type: 1. 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. 2. 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. 3. Burns: partial thickness injury ≤ 9% TBSA. Thermal burn from flame or scald, chemical burns, and electrical burn are included. Radiation and frostbite burns are excluded. 2. Males and females ≥18 years old. 3. Has access to a computer or mobile device for telepresence visits. 4. Able to give informed consent and willing to comply with all required study procedures. Exclusion Criteria: 1. Any wound likely to require irrigation and debridement in an operating room (OR) setting. 2. Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.). 3. \> 72 hrs from initial injury. 4. Pregnant or lactating females. 5. Patients with known allergy(ies) to any of the components of the study irrigation system. 6. Patients who are considered by the investigator for any reason to be an unsuitable candidate.
Contact & Investigator
Shenda Baker, PhD
PRINCIPAL INVESTIGATOR
Synedgen, Inc.
Frequently Asked Questions
Who can join the NCT05743283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Heal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05743283 currently recruiting?
Yes, NCT05743283 is actively recruiting participants. Contact the research team at sb@synedgen.com for enrollment information.
Where is the NCT05743283 trial being conducted?
This trial is being conducted at Washington D.C., United States, St Louis, United States.
Who is sponsoring the NCT05743283 clinical trial?
NCT05743283 is sponsored by Synedgen, Inc.. The principal investigator is Shenda Baker, PhD at Synedgen, Inc.. The trial plans to enroll 100 participants.