Safety Study of Microlyte DualGuard (SAGGA)
6 luglio 2026 aggiornato da: 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).
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
53
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Brad Wiggins, BSN, RN, CBRN
- Numero di telefono: 888-472-9898
- Email: bwiggins@imbedbio.com
Backup dei contatti dello studio
- Nome: Carrie M Huffman, MA, MPH, DLP, RAC-US
- Numero di telefono: 301-337-8159
- Email: chuffman@imbedbio.com
Luoghi di studio
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85008
- Valleywise Health Medical Center
-
Contatto:
- Lora Nordstrom, PHD, BSN, CCRC, CHRC
- Numero di telefono: 602-344-2759
- Email: lora.nordstrom@valleywisehealth.org
-
Investigatore principale:
- Kevin Foster, MD, MBA, FACS
-
-
District of Columbia
-
Washington D.C., District of Columbia, Stati Uniti, 20010
- MedStar Washington Hospital Center
-
Contatto:
- Melissa McLawhorn, RN, BSN
- Numero di telefono: 202-877-6181
- Email: melissa.m.mclawhorn@medstar.net
-
Investigatore principale:
- Jeffrey W Shupp, MD
-
-
Louisiana
-
New Orleans, Louisiana, Stati Uniti, 70112
- University Medical Center New Orleans, LSU Health NOLA
-
Contatto:
- Shana Lennard, RN, BSN, CCRP
- Numero di telefono: 504-702-5171
- Email: slenna@lsuhsc.edu
-
Investigatore principale:
- Jeffrey E Carter, MD, FACS, FABA
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
|
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.
|
|
Comparatore attivo: 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).
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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)
Lasso di tempo: From enrollment to Day 84
|
From enrollment to Day 84
|
|
Adverse event occurrence, including infection
Lasso di tempo: From enrollment to Day 84
|
From enrollment to Day 84
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Debridement - yes or no
Lasso di tempo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Pain as measured using a 10-point VAS
Lasso di tempo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Itching as assessed using a 10-point VAS
Lasso di tempo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Time, in days, to complete DSW closure
Lasso di tempo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Percentage of donor site wound closure at Day 9
Lasso di tempo: Enrollment to Day 9
|
Enrollment to Day 9
|
|
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Lasso di tempo: Day 84
|
Day 84
|
|
Durability of wound closure at 12 weeks
Lasso di tempo: Day 84
|
Day 84
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kevin Foster, MD, MBA, FACS, Valleywise Health Medical Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 agosto 2026
Completamento primario (Stimato)
1 aprile 2027
Completamento dello studio (Stimato)
1 agosto 2027
Date di iscrizione allo studio
Primo inviato
6 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
6 luglio 2026
Primo Inserito (Effettivo)
10 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ID MIDRP 01
- W81XWH-15-9-0001 (Altro identificatore: Department of Defense)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .