Bacterial Infection Clinical Trial
Official title:
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
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.
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 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 because drains may serve as an open channel 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.
Current plastic surgery literature does not provide recommendations or consensus for
antibiotic discontinuation following immediate breast reconstruction. A recent survey
conducted of 650 plastic surgeons showed that 98% of respondents give preoperative
antibiotics, while 91% provide antibiotics for up to 24 hours. Additionally, 71% of
respondents prescribe postoperative outpatient antibiotics. There was a divide of when to
discontinue antibiotics among plastic surgeons who gave them postoperatively. 46% preferred
to continue antibiotics until drain removal, while 52% preferred a specific postoperative
day, most commonly day 5 or 7.
In the same survey, the majority (97%) of surgeons use IV Cefazolin as the choice for
preoperative prophylaxis and oral Cephalexin (75.4%) and Cefadroxil (14.3%) for outpatient
antibiotics. Currently at Stony Brook University Medical Center, patients normally receive
24 hours of IV Cefazolin, followed by postoperative antibiotic prescription for Cefadroxil.
Antibiotics are discontinued when the final drain is removed.
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 will randomize these patients into two groups.
One group will receive the current antibiotic regimen of 24 hours of IV Cefazolin, followed
by outpatient Cefadroxil. Antibiotics will be discontinued for this group once the final
drain is removed. The other group will only receive 24 hours of IV Cefazolin without any
additional outpatient antibiotics, as is recommended for elective clean surgeries. In
patients with penicillin allergies or sensitivity, clindamycin, IV and oral is used. The
same randomization will apply in these patients.
Rationale for early discontinuation of postoperative antibiotics:
Studies have associated prolonged antimicrobial prophylaxis with development of resistant
bacterial strains following surgical procedures. No evidence has been reported supporting
practices of continuing antibiotics until drains are removed. A single dose of preoperative
IV antibiotics has been suggested to be sufficient prophylaxis for most breast surgery
patients discharged home with drains.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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