Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

This study has been completed.
Sponsor:
Collaborator:
Plastic Surgery Educational Foundation
Information provided by (Responsible Party):
Duc T Bui, MD, Stony Brook University
ClinicalTrials.gov Identifier:
NCT01244698
First received: November 18, 2010
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Bacterial Infection
Anti-infective Agents
Breast Implantation
Drug: Cefadroxil discontinued early
Drug: Cefadroxil until drain removal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Surgical Site infection [ Time Frame: 365 days after the procedure ] [ Designated as safety issue: Yes ]

    One or more of the following:

    1. Purulent drainage, with or without laboratory confirmation, from the superficial incision.
    2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
    3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
    4. Diagnosis of superficial incisional SSI by the surgeon or attending physician.


Secondary Outcome Measures:
  • Antibiotic Sensitivity [ Time Frame: From administration of the antibiotic until discontinuation ] [ Designated as safety issue: Yes ]
    Assessed by documentation of an allergic or adverse sensitivity reaction including, but not limited to urticaria, itching, rash, anaphylaxis

  • Clostridium Difficile Colitis [ Time Frame: up to 365 days postoperatively ] [ Designated as safety issue: Yes ]
    C. Difficile colitis will be assessed by documented positive c. difficile toxin assay.

  • Antibiotic Resistance [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: Yes ]
    Local wound infections will be cultured and sent for identification and susceptibility. Alternatively, pathological fluid collections will be aspirated and fluid will be sent for culture and susceptibility. Resistant strains will be documented and treated with alternative antibiotics.

  • Patient compliance [ Time Frame: while antibiotics are being administered postoperatively ] [ Designated as safety issue: No ]
    patients will be asked to bring antibiotics to clinic for counting to assess compliance.

  • Cost [ Time Frame: while antibiotics are being administered postoperatively ] [ Designated as safety issue: No ]
    Cost will be assessed by multiplying the duration of outpatient postoperative antibiotics by the cost for self-pay prescriptions.


Enrollment: 132
Study Start Date: November 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Antibiotics until Drain Removal
All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil until the final drain is removed. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin.
Drug: Cefadroxil until drain removal
All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil (500mg 2 times a day) until the final drain is removed. This is the normal postoperative regimen. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin 600mg IV every 6 hours for 24 hours followed by clindamycin 300mg IV every 6 hours.
Other Names:
  • Duricef
  • Cefazolin
  • Ancef
  • Clindamycin
  • Cleocin
Experimental: Early discontinuation of antibiotics
All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics.
Drug: Cefadroxil discontinued early
All patients will receive 24 hours of IV Cefazolin (1g IV every 8 hr), as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. Clindamycin IV 600mg every 6 hours for 24 hours will be used in penicillin allergic patients.
Other Names:
  • Clindamycin
  • Cleocin
  • Duricef
  • Ancef
  • Cefazolin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244698

Locations
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11792
Sponsors and Collaborators
Stony Brook University
Plastic Surgery Educational Foundation
Investigators
Principal Investigator: Duc T Bui, MD Stony Brook University Medical Center
Study Director: Brett T Phillips, MD Stony Brook University Medical Center
Study Chair: Duc T Bui, MD Stony Brook University Medical Center
  More Information

No publications provided

Responsible Party: Duc T Bui, MD, Associate Professor of Surgery, Stony Brook University
ClinicalTrials.gov Identifier: NCT01244698     History of Changes
Other Study ID Numbers: 160583-3
Study First Received: November 18, 2010
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stony Brook University:
Surgical Site Infection, Breast Reconstruction, Antibiotics

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Cefadroxil
Cefazolin
Clindamycin
Clindamycin-2-phosphate
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014