Safety Study of Microlyte DualGuard

Official title

Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial

Overview

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).

Detailed description

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.

Interventions

• Device Microlyte DualGuard
  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 galliu
• Device Allevyn Foam (Standard of Care Control)
  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.

Primary outcome measures

• 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]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

• 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.
• Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
• All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days).
• Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category).

Exclusion criteria

• 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).
• Serum Creatinine > 2.0 mg/dL.
• Pregnant, lactating or nursing women.
• Unable to provide consent.
• Prior adverse reaction or known sensitivity to silver or gallium.
• Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
• Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
• Any diagnosis with concern for 30-Day mortality.
• Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Valleywise Health Medical Center — Phoenix
• Medstar Washington Hospital Center — Washington D.C.
• University Medical Center New Orleans, LSU Health NOLA — New Orleans

Identifiers

NCT: NCT07695688 · ID MIDRP 01 · W81XWH-15-9-0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗