Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04875728

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

Given IV

Resection

Procedure

Undergo standard of care surgical resection

Other names: Surgical Resection

Primary outcomes

  1. Change in microbiome alpha diversity

    Time frame: 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.

Secondary outcomes

  1. Change in relative abundance of microbes

    Time frame: Baseline, at 2 weeks post-surgery, and 3 months post-surgery

  2. Change in microbiome diversity

    Time frame: 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.

  3. Wound (surgical site) infection rate

    Time frame: Up to 3 months post-surgery

  4. Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines

    Time frame: Up to 3 months post-surgery

    By analysis of composition of circulating immune cell populations and cytokines.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 6, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.