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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Medical Technology Enterprise Consortium | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynEx | Experimental | The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider. |
|
| Saline | Active Comparator | The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynEx Wound Cleanser | Device | SynEx is a concentrated form of SynePure®, an FDA 510(k) cleared aqueous, osmotically balanced wound cleanser containing patented chitosan derivatives. The ingredients are USP purified water, chitosan arginine (a patented chitosan derivative), sorbitol powder, and betaine. SynEx cleanser is packaged in a collapsible plastic pouch for reconstitution in water before debriding and cleansing a wound. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing environment composite score | The composite score is a summation of wound characteristics such size, depth, edges and undermining. Scores range from range of 13 to 60, representing wound regeneration to degeneration respectively). | 14 days |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenda Baker, PhD | Contact | (909) 447-6858 | sb@synedgen.com | |
| Kaveri Parker, PhD | Contact | (909) 447-6858 | kp@synedgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Shenda Baker, PhD | Synedgen, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 22, 2025 | Jan 13, 2026 | 4 |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
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| Saline | Other | The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch. |
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| Barnes Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
|
| D017670 |
| Sodium Compounds |