Safety Study of Microlyte DualGuard

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Imbed Biosciences
Study ID
NCT07695688
Status
Not Yet Recruiting

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Conditions

  • Wound Care
  • Wound Closure

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

First listed
Jul 10, 2026
Start date
Aug 30, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm - Proximal or Distal DSW location
    Treatment with Microlyte DualGuard (investigational device)
  • Active Comparator: Standard of Care Arm - opposite side of DSW from treatment arm
    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).

Primary Outcome Measure

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) [ Time Frame: From enrollment to Day 84 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Valleywise Health Medical CenterPhoenixArizona85008
Lora Nordstrom, PHD, BSN, CCRC, CHRC
[email protected]
602-344-2759
Kevin Foster, MD, MBA, FACS (PRINCIPAL_INVESTIGATOR)
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010
Melissa McLawhorn, RN, BSN
[email protected]
202-877-6181
Jeffrey W Shupp, MD (PRINCIPAL_INVESTIGATOR)
University Medical Center New Orleans, LSU Health NOLANew OrleansLouisiana70112
Shana Lennard, RN, BSN, CCRP
[email protected]
504-702-5171
Jeffrey E Carter, MD, FACS, FABA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Valleywise Health Medical Center· Phoenix, AZMedstar Washington Hospital Center· Washington D.C., DCUniversity Medical Center New Orleans, LSU Health NOLA· New Orleans, LA

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