What side effects are associated with this type of intervention?

Common treatments for wound healing, such as saline, antiseptics (iodine, chlorhexidine), and antimicrobial dressings, can have side effects including local irritation, allergic reactions, and delayed wound healing if the agents are too harsh. Overuse of antimicrobial agents may also lead to resistance. Effective wound care requires balancing cleansing with minimizing tissue damage and promoting healing.

What prior FDA approvals exist?

The FDA has approved several treatments for wound healing that focus on cleansing and antimicrobial action. For instance, products like Dakin's Solution (sodium hypochlorite) and various silver-based dressings have been approved for their antimicrobial properties and ability to cleanse wounds. These treatments help reduce bacterial load and promote a conducive environment for healing. Additionally, products like povidone-iodine and chlorhexidine are commonly used for their antiseptic properties in wound care. These agents are similar in function to the SynEx Wound Cleanser being studied, as they aim to prevent infection and support the healing process.

What other types of research exist?

Promising novel alternatives to SynEx Wound Cleanser for wound healing patients in 2024 include: 1) Hydrofera Blue READY, a foam dressing with antibacterial properties; 2) Prontosan Wound Irrigation Solution, which contains betaine and polyhexanide for effective wound cleansing and antimicrobial action; 3) PHMB (Polyhexamethylene Biguanide) impregnated dressings, known for their broad-spectrum antimicrobial activity; and 4) Silver-based dressings, which offer potent antimicrobial effects and promote wound healing.

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Wound Cleanser

SynEx Wound Rinse for Traumatic Wounds

Q: What is the mechanism of action of this treatment?

Wound cleansing is a critical step in wound management, involving the removal of debris, exudate, and contaminants to create an optimal environment for healing. Antimicrobial agents in wound cleansers play a vital role by reducing the microbial load on the wound surface, thereby preventing or treating infections that can delay healing. These mechanisms are essential for wound healing patients as they help to minimize complications, reduce healing time, and improve overall outcomes.

N/A

Recruiting

Led By Shenda Baker, PhD

Research Sponsored by Synedgen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

Any wound likely to require irrigation and debridement in an operating room (OR) setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to wound cleansing such as skin irritation, allergic reactions if sensitive to ingredients in SynEx, or discomfort during application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My gunshot wound is minor to moderate without major bone or nerve damage.

Select...

I have burns covering 9% or less of my body, not caused by radiation or frostbite.

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I have a recent sharp, puncture, or burn injury on my arm or leg that fits the study's criteria.

Select...

My wound is a deep cut or puncture that does not show bone or muscle and is not due to diabetes, poor vein health, or pressure.

Select...

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

Select...

I have burns covering 9% or less of my body, not caused by radiation or frostbite.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a wound that might need cleaning in surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Wound healing environment composite score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SynExExperimental Treatment1 Intervention

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

Group II: SalineActive Control1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Wound cleansing is a critical step in wound management, involving the removal of debris, exudate, and contaminants to create an optimal environment for healing. Antimicrobial agents in wound cleansers play a vital role by reducing the microbial load on the wound surface, thereby preventing or treating infections that can delay healing. These mechanisms are essential for wound healing patients as they help to minimize complications, reduce healing time, and improve overall outcomes.