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Safety Study of Microlyte DualGuard (SAGGA)

6. Juli 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

53

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85008
        • Valleywise Health Medical Center
        • Kontakt:
        • Hauptermittler:
          • Kevin Foster, MD, MBA, FACS
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20010
        • MedStar Washington Hospital Center
        • Kontakt:
        • Hauptermittler:
          • Jeffrey W Shupp, MD
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • University Medical Center New Orleans, LSU Health NOLA
        • Kontakt:
        • Hauptermittler:
          • Jeffrey E Carter, MD, FACS, FABA

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
Gerät: 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.
Aktiver 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).
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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)
Zeitfenster: From enrollment to Day 84
From enrollment to Day 84
Adverse event occurrence, including infection
Zeitfenster: From enrollment to Day 84
From enrollment to Day 84

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Imbed Biosciences

Mitarbeiter

United States Department of Defense

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. August 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ID MIDRP 01
  • W81XWH-15-9-0001 (Andere Kennung: Department of Defense)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

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