Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Safety Study of Microlyte DualGuard (SAGGA)

6 juillet 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

53

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Carrie M Huffman, MA, MPH, DLP, RAC-US
  • Numéro de téléphone: 301-337-8159
  • E-mail: chuffman@imbedbio.com

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85008
        • Valleywise Health Medical Center
        • Contact:
        • Chercheur principal:
          • Kevin Foster, MD, MBA, FACS
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20010
        • MedStar Washington Hospital Center
        • Contact:
        • Chercheur principal:
          • Jeffrey W Shupp, MD
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70112
        • University Medical Center New Orleans, LSU Health NOLA
        • Contact:
          • Shana Lennard, RN, BSN, CCRP
          • Numéro de téléphone: 504-702-5171
          • E-mail: slenna@lsuhsc.edu
        • Chercheur principal:
          • Jeffrey E Carter, MD, FACS, FABA

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
Dispositif: 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.
Comparateur actif: 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).
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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)
Délai: From enrollment to Day 84
From enrollment to Day 84
Adverse event occurrence, including infection
Délai: From enrollment to Day 84
From enrollment to Day 84

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Imbed Biosciences

Collaborateurs

United States Department of Defense

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 août 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • ID MIDRP 01
  • W81XWH-15-9-0001 (Autre identifiant: Department of Defense)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner