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Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds

NCT05743283 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Wound Heal

Interventions

DEVICE

SynEx 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.

OTHER

Saline

The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Medical Technology Enterprise Consortium

    collaborator UNKNOWN

  • Synedgen, Inc.

    lead INDUSTRY

Principal Investigators

  • Shenda Baker, PhD · Synedgen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743283 on ClinicalTrials.gov