Microlyte DualGuard for Wound Care

(SAGGA Trial)

Not yet recruiting at 2 trial locations
BW
CM
Overseen ByCarrie M Huffman, MA, MPH, DLP, RAC-US
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Imbed Biosciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wound dressing called Microlyte DualGuard to determine its effectiveness in healing skin graft donor sites. It compares this dressing to a standard foam dressing in preventing infections and reducing pain, itching, and scarring. Individuals with a skin graft donor site on their thigh due to a chronic wound, burn, or surgery may qualify. Researchers will monitor participants for 12 weeks to assess wound healing and any side effects. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

What prior data suggests that the Microlyte DualGuard wound dressing is safe for wound care?

Research has shown that Microlyte® DualGuard, a type of wound dressing, is safe for use. This dressing belongs to the Microlyte family, which the FDA has approved for its germ-fighting and pain-relieving properties. It contains a small amount of silver, aiding in wound healing without causing harm. Previous studies have found that similar products in the Microlyte line are well-tolerated, with no major side effects reported. These findings suggest that Microlyte DualGuard should be safe, given its similarity to other FDA-approved products.12345

Why are researchers excited about this trial?

Microlyte DualGuard is unique because it combines advanced materials to promote faster healing in wound care. Unlike standard foam dressings like Allevyn, which primarily focus on moisture management, Microlyte DualGuard incorporates a highly absorbent matrix infused with antimicrobial agents. This innovative composition not only helps maintain optimal moisture levels but also actively combats infection, potentially leading to quicker recovery times. Researchers are excited about this treatment because it offers a dual-action approach that both protects the wound and accelerates healing, which could significantly improve outcomes for patients needing wound care.

What evidence suggests that Microlyte DualGuard is effective for wound care?

Research has shown that Microlyte DualGuard, which participants in this trial may receive, effectively aids wound healing. In earlier studies, 72% of wounds treated with Microlyte healed significantly better, with wound size shrinking by an average of 66% in three weeks. By 12 weeks, 91% of these wounds were either completely healed or nearly healed. The product aims to lower infection risk and reduce pain, both crucial for quicker recovery. This evidence suggests that Microlyte DualGuard could be a promising option for healing certain types of wounds.56789

Who Is on the Research Team?

KF

Kevin Foster, MD, MBA, FACS

Principal Investigator

Valleywise Health Medical Center

Are You a Good Fit for This Trial?

This trial is for people who have partial thickness skin graft donor site wounds and need wound care. Participants will be monitored in the hospital and after discharge, with follow-up visits up to 12 weeks.

Inclusion Criteria

I agree to use effective birth control during the study period.
Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline with minimum 10% enrollment in each FST sub-category
I am at least 22 years old.
See 4 more

Exclusion Criteria

Unable to provide consent
Any diagnosis with concern for 30-Day mortality
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with Microlyte DualGuard or standard of care foam dressing on donor site wounds

12 weeks
Regular clinic visits through 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound healing, infection, pain, itching, and scarring

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Microlyte DualGuard

Trial Overview

The study compares a new wound dressing called Microlyte DualGuard to standard Allevyn Foam dressings. It looks at safety, healing, infection rates, pain, itching, and scarring over a period of 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm - Proximal or Distal DSW locationExperimental Treatment1 Intervention
Group II: Standard of Care Arm - opposite side of DSW from treatment armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Imbed Biosciences

Lead Sponsor

Trials
2
Recruited
150+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

K153756.pdf - accessdata.fda.gov

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