Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction

NCT01244698 | Completed Phase 4

• 1 other identifier: 160583-3
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bacterial Infection; Anti-infective Agents; Breast Implantation

Keywords

Surgical Site Infection, Breast Reconstruction, Antibiotics

Outcome Measures

Primary Outcomes (1)

• Surgical Site infection

  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.

  365 days after the procedure

Secondary Outcomes (5)

• Antibiotic Sensitivity

  From administration of the antibiotic until discontinuation

• Clostridium Difficile Colitis

  up to 365 days postoperatively

• Antibiotic Resistance

  1 year postoperatively

• Patient compliance

  while antibiotics are being administered postoperatively

• Cost

  while antibiotics are being administered postoperatively

Study Arms (2)

Antibiotics until Drain Removal

OTHER

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

Early discontinuation of antibiotics

EXPERIMENTAL

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

Interventions

Cefadroxil discontinued early DRUG

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.

Also known as: Clindamycin, Cleocin, Duricef, Ancef, Cefazolin

Early discontinuation of antibiotics

Cefadroxil until drain removal DRUG

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.

Also known as: Duricef, Cefazolin, Ancef, Clindamycin, Cleocin

Antibiotics until Drain Removal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stony Brook University: lead
• The Plastic Surgery Foundation: collaborator

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11792, United States

Location

Related Publications (1)

• Phillips BT, Fourman MS, Bishawi M, Zegers M, O'Hea BJ, Ganz JC, Huston TL, Dagum AB, Khan SU, Bui DT. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 2016 Jun;222(6):1116-24. doi: 10.1016/j.jamcollsurg.2016.02.018. Epub 2016 Mar 4.

  PMID: 27106640 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Surgical Wound Infection

Interventions

Clindamycin; Cefadroxil; Cefazolin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Cephalexin; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Duc T Bui, MD

  Stony Brook University Medical Center

  PRINCIPAL INVESTIGATOR

• Brett T Phillips, MD

  Stony Brook University Medical Center

  STUDY DIRECTOR

• Duc T Bui, MD

  Stony Brook University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)