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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Microlyte DualGuard
DeviceMicrolyte® 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)
DeviceAllevyn® 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.
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Treatment Arm - Proximal or Distal DSW locationExperimental treatment 1 intervention
Group B: Standard of Care Arm - opposite side of DSW from treatment armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 842
Adverse event occurrence, including infection
Time frame
From enrollment to Day 84Secondary outcomes
1
Debridement - yes or no
Time frame
Enrollment to Day 842
Pain as measured using a 10-point VAS
Time frame
Enrollment to Day 843
Itching as assessed using a 10-point VAS
Time frame
Enrollment to Day 844
Time, in days, to complete DSW closure
Time frame
Enrollment to Day 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imbed Biosciences
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: