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Safety Study of Microlyte DualGuard (SAGGA)

6. juli 2026 oppdatert av: Imbed Biosciences

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

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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

53

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85008
        • Valleywise Health Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kevin Foster, MD, MBA, FACS
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • MedStar Washington Hospital Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jeffrey W Shupp, MD
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • University Medical Center New Orleans, LSU Health NOLA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jeffrey E Carter, MD, FACS, FABA

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. Thigh donor site wound (DSW) location.
  3. At least 22 years of age.
  4. Ability to understand and provide a signed and dated informed consent form.
  5. Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
  6. 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).
  7. 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:

  1. DSW size of > 310 cm2
  2. Calculated glomerular filtration rate (GFR) <60 ml/min
  3. Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
  5. Serum Creatinine > 2.0 mg/dL.
  6. Pregnant, lactating or nursing women.
  7. Unable to provide consent.
  8. Prior adverse reaction or known sensitivity to silver or gallium.
  9. Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
  10. 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.
  11. Any diagnosis with concern for 30-Day mortality.
  12. Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
Enhet: 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 gallium only to prevent or minimize microbial growth within the dressing.
Aktiv komparator: Standard of Care Arm - opposite side of DSW from treatment arm
The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard. The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn).
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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)
Tidsramme: From enrollment to Day 84
From enrollment to Day 84
Adverse event occurrence, including infection
Tidsramme: From enrollment to Day 84
From enrollment to Day 84

Sekundære resultatmål

Resultatmål
Tidsramme
Debridement - yes or no
Tidsramme: Enrollment to Day 84
Enrollment to Day 84
Pain as measured using a 10-point VAS
Tidsramme: Enrollment to Day 84
Enrollment to Day 84
Itching as assessed using a 10-point VAS
Tidsramme: Enrollment to Day 84
Enrollment to Day 84
Time, in days, to complete DSW closure
Tidsramme: Enrollment to Day 84
Enrollment to Day 84
Percentage of donor site wound closure at Day 9
Tidsramme: Enrollment to Day 9
Enrollment to Day 9
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Tidsramme: Day 84
Day 84
Durability of wound closure at 12 weeks
Tidsramme: Day 84
Day 84

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Imbed Biosciences

Samarbeidspartnere

United States Department of Defense

Etterforskere

  • Hovedetterforsker: Kevin Foster, MD, MBA, FACS, Valleywise Health Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. august 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

6. juli 2026

Først innsendt som oppfylte QC-kriteriene

6. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ID MIDRP 01
  • W81XWH-15-9-0001 (Annen identifikator: Department of Defense)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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