Safety Study of Microlyte DualGuard

Starting soon · Not applicable

Conditions studied: Wound Closure, Wound Care

In brief

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).

Key facts

Study ID

NCT07695688

Run by

Imbed Biosciences

People needed

53

Starts

2026-08-30

Expected to finish

2027-08-01

Last updated by the study team

2026-07-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Thigh donor site wound (DSW) location.
• At least 22 years of age.
• Ability to understand and provide a signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
• 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).
• 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).

You may not qualify if…

• DSW size of > 310 cm2
• Calculated glomerular filtration rate (GFR) <60 ml/min
• Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
• Serum Creatinine > 2.0 mg/dL.
• Pregnant, lactating or nursing women.
• Unable to provide consent.
• Prior adverse reaction or known sensitivity to silver or gallium.
• Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
• 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.
• Any diagnosis with concern for 30-Day mortality.
• Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.

Where it is running

• 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

Full record on ClinicalTrials.gov

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