Safety Study of Microlyte DualGuard (SAGGA)
6 de julho de 2026 atualizado por: 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Estimado)
53
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Brad Wiggins, BSN, RN, CBRN
- Número de telefone: 888-472-9898
- E-mail: bwiggins@imbedbio.com
Estude backup de contato
- Nome: Carrie M Huffman, MA, MPH, DLP, RAC-US
- Número de telefone: 301-337-8159
- E-mail: chuffman@imbedbio.com
Locais de estudo
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85008
- Valleywise Health Medical Center
-
Contato:
- Lora Nordstrom, PHD, BSN, CCRC, CHRC
- Número de telefone: 602-344-2759
- E-mail: lora.nordstrom@valleywisehealth.org
-
Investigador principal:
- Kevin Foster, MD, MBA, FACS
-
-
District of Columbia
-
Washington D.C., District of Columbia, Estados Unidos, 20010
- MedStar Washington Hospital Center
-
Contato:
- Melissa McLawhorn, RN, BSN
- Número de telefone: 202-877-6181
- E-mail: melissa.m.mclawhorn@medstar.net
-
Investigador principal:
- Jeffrey W Shupp, MD
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70112
- University Medical Center New Orleans, LSU Health NOLA
-
Contato:
- Shana Lennard, RN, BSN, CCRP
- Número de telefone: 504-702-5171
- E-mail: slenna@lsuhsc.edu
-
Investigador principal:
- Jeffrey E Carter, MD, FACS, FABA
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
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)
Prazo: From enrollment to Day 84
|
From enrollment to Day 84
|
|
Adverse event occurrence, including infection
Prazo: From enrollment to Day 84
|
From enrollment to Day 84
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Debridement - yes or no
Prazo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Pain as measured using a 10-point VAS
Prazo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Itching as assessed using a 10-point VAS
Prazo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Time, in days, to complete DSW closure
Prazo: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Percentage of donor site wound closure at Day 9
Prazo: Enrollment to Day 9
|
Enrollment to Day 9
|
|
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Prazo: Day 84
|
Day 84
|
|
Durability of wound closure at 12 weeks
Prazo: Day 84
|
Day 84
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kevin Foster, MD, MBA, FACS, Valleywise Health Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
30 de agosto de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
6 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de julho de 2026
Primeira postagem (Real)
10 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ID MIDRP 01
- W81XWH-15-9-0001 (Outro identificador: Department of Defense)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .