Status:
WITHDRAWN
Antibiotics and Tissue Expanders in Breast Reconstruction
Lead Sponsor:
Emory University
Conditions:
Complications; Breast Prosthesis, Infection or Inflammation
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 brea...
Detailed Description
Surgical site infections occur in up to one-third of patients who undergo implant-based breast reconstruction following mastectomy for cancer; most of such cases require subsequent prosthetic removal....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01899690
Start Date
June 1 2016
End Date
December 1 2017
Last Update
February 24 2017
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