Safety Study of Microlyte DualGuard

NCT07695688 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: ID MIDRP 01W81XWH-15-9-0001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Wound Closure; Wound Care

Keywords

Donor site wound; antimicrobial; wound dressing

Outcome Measures

Primary Outcomes (2)

• Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28)

  From enrollment to Day 84

• Adverse event occurrence, including infection

  From enrollment to Day 84

Secondary Outcomes (7)

• Debridement - yes or no

  Enrollment to Day 84

• Pain as measured using a 10-point VAS

  Enrollment to Day 84

• Itching as assessed using a 10-point VAS

  Enrollment to Day 84

• Time, in days, to complete DSW closure

  Enrollment to Day 84

• Percentage of donor site wound closure at Day 9

  Enrollment to Day 9

Study Arms (2)

Treatment Arm - Proximal or Distal DSW location

EXPERIMENTAL

Treatment with Microlyte DualGuard (investigational device)

Device: Microlyte DualGuard

Standard of Care Arm - opposite side of DSW from treatment arm

ACTIVE COMPARATOR

The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard. The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn).

Device: Allevyn Foam (Standard of Care Control)

Interventions

Microlyte DualGuard DEVICE

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.

Treatment Arm - Proximal or Distal DSW location

Allevyn Foam (Standard of Care Control) DEVICE

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.

Standard of Care Arm - opposite side of DSW from treatment arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Imbed Biosciences: lead
• United States Department of Defense: collaborator

Study Sites (3)

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University Medical Center New Orleans, LSU Health NOLA

New Orleans, Louisiana, 70112, United States

Location

Study Officials

• Kevin Foster, MD, MBA, FACS

  Valleywise Health Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brad Wiggins, BSN, RN, CBRN

CONTACT

888-472-9898; bwiggins@imbedbio.com

Carrie M Huffman, MA, MPH, DLP, RAC-US

CONTACT

301-337-8159; chuffman@imbedbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open label, randomized, split-wound controlled trial

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)