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
Sponsors and collaborators
Imbed Biosciences
Lead sponsor
United States Department of Defense
Collaborator