Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Completed · Phase 4

Conditions studied: Bacterial Infection, Anti-infective Agents, Breast Implantation

In brief

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 routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.

Key facts

Study ID

NCT01244698

Run by

Stony Brook University

People needed

132

Starts

2010-11-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stony Brook University Medical Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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