NCT04875728Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 5 Oct 2020
- Start date
- 8 Sept 2020
- Primary completion date
- 2 Feb 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT04875728
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 8 Sept 2020 to the primary completion date, 2 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics within the three months prior to surgery
- 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
Other illness
- 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)
Other
- American Society of Anesthesiologists (ASA) grade \> IV
- Refusal to participate in the study
- Patients who are pregnant will not be included in this study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.