Clinical trial · Interventional
Microbiome and Association With Implant Infections
Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction
- 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)
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Genetic Predisposition to Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cephalexin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A: Standard antibiotics
- description
- Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
- interventionNames
- Drug: Cephalexin
- type
- NO_INTERVENTION
- label
- Cohort B: No antibiotics
- description
- Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
Primary outcomes (6)
- measure
- Proportion of tissue samples obtained successfully over time
- timeFrame
- 90 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer. 2. Age \>= 18 years 3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement 4. Ability to understand a written informed consent document, and the willingness to sign it 5. At least 4 weeks post-completion of chemotherapy or radiation therapy. Exclusion Criteria: 1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 2. Pregnant or breastfeeding 3. Patients who have taken antibiotics within 90 days of the consent date 4. Patients who have taken probiotics within 90 days of the consent date 5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study 6. Male patients
References
Publications (0)
Data not yet available