RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-12

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05743283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Shenda Baker, PhD

CONTACT

(909) 447-6858

sb@synedgen.com

Kaveri Parker, PhD

CONTACT

(909) 447-6858

kp@synedgen.com

Principal Investigator

Shenda Baker, PhD

PRINCIPAL_INVESTIGATOR

Synedgen, Inc.

Study Locations (Sites)

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Synedgen, Inc.

Shenda Baker, PhD, PRINCIPAL_INVESTIGATOR, Synedgen, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-04-12

Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

Wound Heal