Gulluoglu, B.M., Guler, S.A., Ugurlu, M.U., & Culha, G. (2013). Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: A randomized controlled trial. Annals of Surgery, 257, 37–43.

DOI Link

Study Purpose

To assess the effectiveness of prophylactic antibiotics on prevention of surgical site infection (SSI) and the cost of this effectiveness, as compared to a control without prophylaxis antibiotics in early breast cancer surgery in overweight or obese women

Intervention Characteristics/Basic Study Process

Women randomly were assigned to receive IV infusion of 1 g ampicillin-sulbactam at the start of anesthesia or no prophylactic antibiotics. Patients were followed for 30 days. Outcomes also were compared to a group of women who had a body mass index (BMI) lower than 25 and who did not receive antibiotic prophylaxis.

Sample Characteristics

  • N = 369 (187 in the prophylaxis group, 182 in the control group)
  • AGE = 58 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: BMI of 25 or higher; all had nonrecurrent, operable breast cancer

Setting

  • SITE: Single site 
  • SETTING TYPE: Inpatient 
  • LOCATION: Tertiary university hospital in Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • Phase IV, randomized, controlled, parallel-group

Measurement Instruments/Methods

  • SSI was defined as infection within 30 days post-operation with one of the following.
    • Purulent drainage from incision
    • Organisms isolated from incision cultures
    • Localized pain
    • Tenderness
    • Swelling
    • Redness of an incision deliberately opened by the surgeon
  • ASA class

Results

Nine SSIs developed in the prophylaxis group, versus 25 in the control group (p = .002). Patients were matched well according to age, BMI, history of smoking, ASA class, interval between tissue biopsy and randomization, clinical cancer stage, type of breast and axillary surgery, operation time, hospital stay, and post-operation complications. All SSIs were discovered within post-operation week one after discharge, except one. The control group had significantly more SSIs compared to those in the normal-weight comparison group (p = .0007) and higher SSI treatment costs than the prophylaxis group (p = .007). Patients in the control group had more open surgical biopsies than those in the prophylaxis group (p = .004)

Conclusions

The administration of antibiotics at the time of induction for surgery was associated with reduced incidence of SSI among obese women undergoing breast cancer surgery. Costs were lower among those receiving prophylactic antibiotics.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias(sample characteristics)
  • Other limitations/explanation: The control group underwent more biopsies prior to surgery; mastectomy is more common in Turkish culture.

Nursing Implications

Reminding physicians to prescribe pre-operation antibiotics is important. Administration of a dose of IV antibiotics at the time of induction is a current U.S. standard of care and recommendation for SSI prevention. Careful hand washing and clean dressing changes are imperative. These findings also point to the increased risk of infection associated with obesity. Nurses can educate patients regarding risks associated with obesity and assist patients with weight management.