Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage IA Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IB Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage I Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIA Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIC Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IA Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Pathologic Stage IB Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefazolin | Drug | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (cefazolin, surgical resection)
- description
- Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.
- interventionNames
- Drug: Cefazolin
- Procedure: Resection
- type
- EXPERIMENTAL
- label
- Arm B (surgical resection)
- description
- Patients undergo standard of care surgical resection.
- interventionNames
- Procedure: Resection
Primary outcomes (1)
- measure
- Change in microbiome alpha diversity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available