Clinical trial · Interventional
Antibiotics and Tissue Expanders in Breast Reconstruction
Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was withdrawn prior to IRB approval.
Summary
Brief summary (as posted)
This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. The investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complications; Breast Prosthesis, Infection or Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antibiotic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- antibiotic
- description
- 7 days of preventive antibiotics after surgery
- interventionNames
- Drug: antibiotic
- type
- NO_INTERVENTION
- label
- No antibiotic
- description
- No preventive postoperative antibiotics
Primary outcomes (1)
- measure
- Surgical site infection
- timeFrame
- one year
- description
- Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus. * Ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by Emory University Hospital and affiliates. Exclusion Criteria: * Pregnancy * Incarceration * Non-implant based reconstructive plan * Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
References
Publications (0)
Data not yet available