The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Clinical Stage I Cutaneous Melanoma AJCC v8 · Clinical Stage IA Cutaneous Melanoma AJCC v8 · Clinical Stage IB Cutaneous Melanoma AJCC v8 · Clinical Stage II Cutaneous Melanoma AJCC v8 · Clinical Stage IIA Cutaneous Melanoma AJCC v8 · Clinical Stage IIB Cutaneous Melanoma AJCC v8 · Clinical Stage IIC Cutaneous Melanoma AJCC v8 · Pathologic Stage I Cutaneous Melanoma AJCC v8 · Pathologic Stage IA Cutaneous Melanoma AJCC v8 · Pathologic Stage IB Cutaneous Melanoma AJCC v8 · Pathologic Stage II Cutaneous Melanoma AJCC v8 · Pathologic Stage IIA Cutaneous Melanoma AJCC v8 · Pathologic Stage IIB Cutaneous Melanoma AJCC v8 · Pathologic Stage IIC Cutaneous Melanoma AJCC v8
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 20 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.
Leer la descripción completa
PRIMARY OBJECTIVE:
I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.
SECONDARY OBJECTIVES:
I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.
II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.
ARM B: Patients undergo standard of care surgical resection.
After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adult subjects with early stage melanoma (stage I-II)
- Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
- Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion Criteria:
- Use of antibiotics within the three months prior to surgery
- Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
- Presence of an infection at the time of surgery
- Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
- Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
- American Society of Anesthesiologists (ASA) grade \> IV
- Refusal to participate in the study
- Patients who are pregnant will not be included in this study
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Arm A (cefazolin, surgical resection)
Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
Drug: Cefazolin · Procedure: Resection
Arm B (surgical resection)
Patients undergo standard of care surgical resection.
Procedure: Resection
Cefazolin DRUG
Given IV
Resection PROCEDURE
Undergo standard of care surgical resection
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in microbiome alpha diversity
Plazo: Baseline up to 2 weeks post-surgery
The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
Medidas secundarias
Change in relative abundance of microbes
Plazo: Baseline, at 2 weeks post-surgery, and 3 months post-surgery
No informado en este registro.
Change in microbiome diversity
Plazo: Baseline up to 3 months post-surgery
The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample.
Wound (surgical site) infection rate
Plazo: Up to 3 months post-surgery
No informado en este registro.
Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines
Plazo: Up to 3 months post-surgery
By analysis of composition of circulating immune cell populations and cytokines.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
M D Anderson Cancer CenterHouston, Texas, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- M.D. Anderson Cancer Center
- Inicio del estudio
- 8 sept 2020 Real
- Finalización primaria
- 2 feb 2027 Estimado
- Finalización del estudio
- 2 feb 2027 Estimado
- Primera publicación
- 6 may 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026