Safety Study of Microlyte DualGuard

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorImbed Biosciences

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Microlyte DualGuard
  • Allevyn Foam (Standard of Care Control)

Treatment groups

53 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Imbed Biosciences

Lead sponsor

United States Department of Defense

Collaborator