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NCT07695688

Safety Study of Microlyte DualGuard

Sponsor: Imbed Biosciences

View on ClinicalTrials.gov

Summary

The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).

Official title: Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-30

Completion Date

2027-08

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Wound Closure Wound Care

Interventions

DEVICE

Microlyte DualGuard

Microlyte® DualGuard wound dressing: It is a sterile, single use synthetic polyvinyl alcohol absorbent sheet with ionic gallium, and with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver and gallium with maximum of 0.16 mg/sq. in. and 1 mg/sq. in., respectively. Microlyte® DualGuard wound dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver and gallium only to prevent or minimize microbial growth within the dressing.

DEVICE

Allevyn Foam (Standard of Care Control)

Allevyn® is indicated for as wound management by secondary intention on shallow, granulating wounds, chronic and acute exuding wounds, full- and partial-thickness wounds including: leg ulcers, diabetic foot ulcers, surgical wounds, first- and second-degree burns, skin graft donor site, skin tears, and pressure injuries.

Inclusion Criteria: 1. Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision is indicated. 2. Thigh donor site wound (DSW) location. 3. At least 22 years of age. 4. Ability to understand and provide a signed and dated informed consent form. 5. Stated willingness to comply with all study procedures and availability for all visits for the duration of the study. 6. All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days). 7. Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category). Exclusion Criteria: 1. DSW size of \> 310 cm2 2. Calculated glomerular filtration rate (GFR) \<60 ml/min 3. Hypocalcemia defined as serum corrected calcium of \<8.0 mg/dl 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times the upper limit of normal (ULN). 5. Serum Creatinine \> 2.0 mg/dL. 6. Pregnant, lactating or nursing women. 7. Unable to provide consent. 8. Prior adverse reaction or known sensitivity to silver or gallium. 9. Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study. 10. Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc. 11. Any diagnosis with concern for 30-Day mortality. 12. Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.

Locations (3)

Valleywise Health Medical Center

Phoenix, Arizona, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

University Medical Center New Orleans, LSU Health NOLA

New Orleans, Louisiana, United States