Wound HealNCT05743283
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds
A study testing SynEx Wound Cleanser and Saline in people with Wound Heal, run by Synedgen, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- SynEx Wound Cleanser and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Jamie Mills, BS, CCRC, 314-273-1382, jamiem@wustl.edu
Stephen Liang, MD
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Alison Ross, 202-877-4707, Alison.R.Ross@medstar.net
About this study
Official title: Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
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
- Being tested
- SynEx Wound Cleanser, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynEx Wound CleanserDevice
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.
SalineOther
The saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch.
| Study group | Role | What they receive |
|---|---|---|
| SynEx | Experimental | The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider. Receives: Device: SynEx Wound Cleanser |
| Saline | Active comparator | The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start12 Apr 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synedgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Medical Technology Enterprise Consortium
- Responsible party
- Sponsor
- Investigators
- Shenda Baker, PhD, Principal investigator, Synedgen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743283
- Sponsor's protocol ID
- SynEx
- Status last verified
- May 2024
- First submitted
- 14 Feb 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of SynEx™ Wound Rinse in Civilian Surrogates of Combat Injury Wounds
- ClinicalTrials.gov ID
- NCT05743283
- Acronym / sponsor ID
- SynEx
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Synedgen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Medical Technology Enterprise Consortium
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, comparator-controlled interventional study to assess clinical efficacy of SynEx Wound Cleanser.
| Arm | Type | Receives |
|---|---|---|
| SynEx | Experimental | Device: SynEx Wound CleanserThe experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider. |
| Saline | Active comparator | Other: SalineThe comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynEx Wound CleanserSynEx 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. | Device | SynEx |
| SalineThe saline solution is composed of water and salt. It is packaged in a collapsible plastic pouch. | Other | Saline |
Primary outcome
Wound healing environment composite score
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shenda Baker, PhD principal investigator
Synedgen, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SynEx Wound Cleanser and Saline in people with Wound Heal, run by Synedgen, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenda Baker, PhD ((909) 447-6858, sb@synedgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing environment composite score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.