NCT05743283 · Synedgen, Inc.
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and
Exclusion criteria
- for the wound type:
- 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.
- 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.
- Males and females ≥18 years old.
- Has access to a computer or mobile device for telepresence visits.
- Able to give informed consent and willing to comply with all required study procedures. Exclusion Criteria:
- Any wound likely to require irrigation and debridement in an operating room (OR) setting.
- 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.).
- \> 72 hrs from initial injury.
- Pregnant or lactating females.
- Patients with known allergy(ies) to any of the components of the study irrigation system.
- Patients who are considered by the investigator for any reason to be an unsuitable candidate.
Where
- Washington D.C., District of Columbia
- St Louis, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 16, 2024 · Source of record for eligibility and locations