Status:
COMPLETED
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
The Plastic Surgery Foundation
Conditions:
Bacterial Infection
Anti-infective Agents
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinel...
Detailed Description
Background: Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All patients presenting to Stony Brook University Medical Center Plastic Surgery clinic for immediate breast reconstruction using a tissue expander.
- Age 18 years or older
- Exclusion Criteria
- Delayed or revision implant reconstruction
- Refusal or inability to consent
- Contraindications to surgery as determined by attending physician
- Contraindications to both penicillin/cephalosporin and clindamycin antibiotics (significant allergies)
- Patients with serious existing systemic infection, defined as 2 or more of the following:
- Peripheral body temperature \>38 degrees Celsius CRP \>5g/L Leukocytes \> 12,000/microliter
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01244698
Start Date
November 1 2010
End Date
May 1 2014
Last Update
May 13 2014
Active Locations (1)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11792