NCT04875728

The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Cefazolin	Given IV
PROCEDURE	Resection	Undergo standard of care surgical resection

Timeline

• Start date: 2020-09-08
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-05-06
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study