Melanoma Clinical Trial
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Houston Texas, 77030, United States
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