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.
Additional locations may be listed on ClinicalTrials.gov for NCT04875728.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Emily Z. Keung
Phone: 713-792-6940
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.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorEmily Z. Keung
