SynEx Wound Rinse for Traumatic Wounds

Recruiting at 3 trial locations

Overseen By Kaveri Parker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synedgen, Inc.

Disqualifiers: Pregnancy, Lactation, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wound cleanser called SynEx for individuals with specific traumatic wounds, such as gunshot, puncture, or burn injuries. The researchers aim to determine if SynEx improves wound healing compared to the usual saline rinse (a sodium chloride solution). Participants will use either SynEx or saline and report on their wound healing progress. Individuals with recent (within 72 hours) penetrating or burn wounds on their arms or legs who can attend study visits online may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to the development of innovative wound care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SynEx Wound Cleanser is safe to use. A related study found that using this product with another wound care item can speed up healing and lower infection rates in some burn wounds, suggesting that SynEx is likely well-tolerated.

However, detailed safety information on SynEx Wound Cleanser alone remains limited. This trial compares it to saline, a common treatment, to assess whether SynEx is equally safe for cleaning wounds. Researchers will closely monitor participants to quickly address any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SynEx Wound Cleanser is unique because it offers an innovative approach to cleaning traumatic wounds. Unlike traditional saline solutions that simply wash debris away, SynEx is designed to actively target and remove harmful bacteria from the wound site, potentially reducing the risk of infection. Researchers are excited about SynEx because it could lead to faster healing times and better outcomes for patients with traumatic wounds, combining effective cleansing with antibacterial properties in one solution.

What evidence suggests that SynEx Wound Cleanser is effective for traumatic wounds?

This trial will compare SynEx Wound Cleanser with Saline Solution for cleansing traumatic wounds. Research has shown that SynEx Wound Cleanser might aid in healing traumatic wounds. Early results suggest it could speed up healing and reduce infection risk. SynEx is designed to clean wounds more effectively than regular saline. It is believed to work well on serious injuries like gunshot wounds, deep cuts, or burns. While more information is needed, early findings are promising for improved wound care. ^{1 2 3 6 7}

Who Is on the Research Team?

Shenda Baker, PhD

Principal Investigator

Synedgen, Inc.

Are You a Good Fit for This Trial?

Adults with certain types of wounds—like gunshot, penetrating, or burn wounds—but not diabetic ulcers or severe injuries needing surgery. Participants must be over 18, able to use a computer or mobile for virtual visits, and willing to follow the study's procedures.

Inclusion Criteria

My gunshot wound is small and without major bone or nerve damage.

My wound is a deep cut or puncture that does not show bone or muscle.

Has access to a computer or mobile device for telepresence visits.

Exclusion Criteria

Pregnant or lactating females

It has been more than 72 hours since my injury occurred.

I have a wound that might need cleaning in surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either SynEx Wound Cleanser or Saline Solution for wound care

2 weeks

Up to 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Saline
• SynEx Wound Cleanser

Trial Overview The trial is testing SynEx Wound Cleanser against routine saline treatment in people with traumatic wounds. It involves up to four visits where participants will use their assigned cleanser and report on their healing process.

How Is the Trial Designed?

Group I: SynEx Experimental Treatment 1 Intervention

The experimental arm will receive SynEx Wound Cleanser to cleanse the wound as directed by their healthcare provider.

Group II: Saline Active Control 1 Intervention

The comparator arm will receive Saline Solution to cleanse the wound as directed by their healthcare provider.

SynEx Wound Cleanser is already approved in United States for the following indications:

Approved in United States as SynEX for:

• Traumatic wounds
• Gunshot wounds
• Penetrating wounds
• Burn wounds

Who Is Running the Clinical Trial?

Synedgen, Inc.

Lead Sponsor

Trials

3

Recruited

130+

Medical Technology Enterprise Consortium

Collaborator

Trials

3

Recruited

340+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Using a pH-balanced skin cleanser around pressure ulcers significantly speeds up healing compared to using normal saline, especially for stage II ulcers, which showed a 1.79-fold improvement in healing rate.

The study involved patients aged 65 and older in a long-term care hospital over two years, demonstrating that proper skin cleansing can enhance recovery from pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of a cleanser on skin surrounding pressure ulcers in older people promote healing? Konya, C., Sanada, H., Sugama, J., et al.[2006]

In an in-vitro study using human plasma as a wound coating, saline and Ringer's solutions, along with a betaine surfactant solution, effectively removed harmful protein coatings from wounds, which is crucial for promoting healing.

In contrast, an antiseptic solution (Octenisept) caused the wound coatings to become fixed and insoluble, potentially hindering the healing process and increasing the risk of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vitro test for comparing the efficacy of wound rinsing solutions. Kaehn, K., Eberlein, T.[2014]

Wound cleansing is an essential practice in healthcare, but there is still uncertainty about the best techniques and frequency for cleaning wounds.

The article introduces Steripod normal saline by SSL International as a new product aimed at improving wound cleansing, highlighting the need for modern approaches in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound irrigation techniques: new Steripod normal saline. Williams, C.[2015]

Cleansing products for chronic wounds are essential for maintaining wound hygiene and promoting healing, as they help remove debris and bacteria.

The guide outlines various types of cleansing products, emphasizing their properties and appropriate uses to ensure effective wound care and minimize infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound cleansing agents. Thomas, S.[2019]

In a study comparing various wound-rinsing solutions using three different in vitro models, physiological saline was found to be more effective than ringer lactate for decontaminating proteins in a one-chamber model.

The flow-cell method proved to be the most reliable for detecting differences in cleansing efficiency among solutions, with water outperforming saline, while ringer lactate showed the least effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of three experimental in vitro models for the assessment of the mechanical cleansing efficacy of wound irrigation solutions. Klasinc, R., Augustin, LA., Below, H., et al.[2021]

Wound cleansing is crucial for effective wound care, but improper techniques or solutions can harm patient outcomes, highlighting the need for proper training among nurses.

Nurses must assess wounds holistically and choose appropriate cleansing methods and solutions to ensure safe and effective wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to cleanse a wound. Wynn, M.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05743283

Efficacy of SynEx Wound Rinse in Civilian Surrogates ... The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2023-d23da

SynEx Wound Rinse for Traumatic Wounds This trial is testing a new wound cleaner called SynEx Wound Cleanser. It focuses on people with serious injuries like gunshot, penetrating, or burn wounds.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05743283?tab=history&a=4

Record History | ver. 4: 2024-05-15 | NCT05743283 A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

4. synedgen.com synedgen.com/synedgen-initiates-clinical-trial-assessing-combination-of-synepure-and-catasyn-for-the-treatment-of-partial-thickness-burns/

Synedgen Initiates Clinical Trial Assessing Combination of ... “We believe the combination of our two wound care products is not only safe but improves time-to-heal and infection rates in superficial partial ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05743283?keyword=%22Wound%20Heal%22

San Mateo Clinical Trial Efficacy of SynEx Wound Rinse in ... The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds.

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0089453

Promotion of wound healing (DBCOND0089453) A serine protease inhibitor used to reduce the risk for perioperative blood loss and the need for blood transfusion in high-risk patients during ...

7. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT05743283?keyword=%22Wound%20Heal%22

Lake Clinical Trial Efficacy of SynEx Wound Rinse in Civilian ... The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds.