SynEx Wound Rinse for Traumatic Wounds

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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. The goal is to see if SynEx can clean these wounds better, helping them heal faster and reducing infection risks.

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.

What evidence supports the effectiveness of the treatment SynEx Wound Cleanser for traumatic wounds?

Research suggests that saline solutions, like those in SynEx Wound Cleanser, are effective in cleaning wounds by removing debris and reducing bacteria, which can help promote healing. Studies comparing different wound-rinsing solutions found that saline was effective in decontaminating proteins, which is important for wound cleanliness and healing. ^{1 2 3 4 5}

How is the SynEx Wound Cleanser treatment different from other treatments for traumatic wounds?

The SynEx Wound Cleanser is unique because it may contain specific ingredients or a formulation that differs from standard saline or antiseptic solutions, potentially offering a novel approach to wound cleansing. However, the available research does not provide specific details about its unique properties compared to other wound rinsing solutions. ^{1 2 3 5 6}

Research Team

Shenda Baker, PhD

Principal Investigator

Synedgen, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Wound cleansing agents. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of three experimental in vitro models for the assessment of the mechanical cleansing efficacy of wound irrigation solutions. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Does the use of a cleanser on skin surrounding pressure ulcers in older people promote healing? [2006]

5. England pubmed.ncbi.nlm.nih.gov

How to cleanse a wound. [2022]

6. England pubmed.ncbi.nlm.nih.gov

In-vitro test for comparing the efficacy of wound rinsing solutions. [2014]