Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Condition(s) targeted: Bacterial Infection; Anti-infective Agents; Breast Implantation

Intervention: Cefadroxil discontinued early (Drug); Cefadroxil until drain removal (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stony Brook University

Official(s) and/or principal investigator(s):
Duc T Bui, MD, Principal Investigator, Affiliation: Stony Brook University Medical Center
Brett T Phillips, MD, Study Director, Affiliation: Stony Brook University Medical Center
Duc T Bui, MD, Study Chair, Affiliation: Stony Brook University Medical Center

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.

Official title: Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Surgical Site infection

Secondary outcome:

Antibiotic Sensitivity

Clostridium Difficile Colitis

Antibiotic Resistance

Patient compliance

Cost

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Stony Brook University Medical Center, Stony Brook, New York 11792, United States

Starting date: November 2010
Last updated: May 12, 2014