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).
This study is a multi-center randomized, controlled, open-label, split-wound clinical trial to assess the safety and potential effectiveness in wound healing of the Microlyte® DualGuard wound dressing in surgically created partial-thickness donor site wounds (DSW) on patients requiring split-thickness skin grafting. This clinical trial is designed to demonstrate safety and effectiveness of the Microlyte® DualGuard wound dressing. We note that this clinical trial is designed for the management of surgically created clean acute donor-site wounds. These surgically clean acute wounds have high tendency to heal with the standard of care if supervised diligently, especially under the monitoring of a clinical trial. Donor site wounds are created regularly in surgical hospitals as a means to utilize split-thickness skin grafts for closure of chronic, traumatic, infectious, oncologic, burn and other wounds. A donor site wound is a reproducible partial thickness wound. At the same time, it is associated with morbidity including pain, long healing times, risk of infection, and long-term cosmetic changes. Thus, it is the ideal model for assessment of safety and effectiveness of topical products engineered for wound healing and infection control. The donor site can easily be divided into two halves that are amenable to randomization using intra-patient controls to maximize the chances of assessing safety and effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
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® 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.
Valleywise Health Medical Center
Phoenix, Arizona, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University Medical Center New Orleans, LSU Health NOLA
New Orleans, Louisiana, United States
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
Adverse event occurrence, including infection
Time frame: From enrollment to Day 84
Debridement - yes or no
Time frame: Enrollment to Day 84
Pain as measured using a 10-point VAS
Time frame: Enrollment to Day 84
Itching as assessed using a 10-point VAS
Time frame: Enrollment to Day 84
Time, in days, to complete DSW closure
Time frame: Enrollment to Day 84
Percentage of donor site wound closure at Day 9
Time frame: Enrollment to Day 9
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Time frame: Day 84
Durability of wound closure at 12 weeks
Time frame: Day 84
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NONE
Enrollment
53