Wound Heal
Conditions
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.
Interventions
DEVICESynEx Wound Cleanser
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.
OTHERSaline
The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.
Sponsors
United States Department of Defense
Medical Technology Enterprise Consortium
Synedgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing environment composite score | 14 days | 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). |
Countries
United States
Contacts
Primary ContactShenda Baker, PhD
Backup ContactKaveri Parker, PhD
Outcome results
None listed