Status:
ACTIVE_NOT_RECRUITING
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage I Cutaneous Melanoma AJCC v8
Clinical Stage IA Cutaneous Melanoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 OBJ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04875728
Start Date
September 8 2020
End Date
February 2 2027
Last Update
November 17 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030