Ishibashi, K., Ishida, H., Kuwabara, K., Ohsawa, T., Okada, N., Yokoyama, M., & Kumamoto, K. (2014). Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: Results of a prospective randomized non-inferiority trial. Surgery Today, 44, 716–722.

DOI Link

Study Purpose

To investigate the effects of single-dose versus multiple-dose antimicrobial prophylaxis on surgical site infections (SSI) in patients undergoing elective surgery for rectal cancer

Intervention Characteristics/Basic Study Process

All patients received a preoperative bowel cleansing, kanamycin and erythromycin orally within 24 hours prior to surgery, and 1 g of a second-generation cephalosporin IV perioperatively. After surgery, patients were randomized to receive either single-dose prophylaxis one hour after surgery or an additional five doses over two consecutive days. Wounds were inspected daily in the hospital and in the clinic 30 days after surgery. The trial was designed to detect a 10% difference in the incidence of SSIs between groups.

Sample Characteristics

  • N = 279  
  • MEAN AGE = 65 years (range = 33–91 years)
  • MALES: 64.5%, FEMALES: 35.5%
  • KEY DISEASE CHARACTERISTICS: All patients had rectal cancer; the majority had anterior resections
  • OTHER KEY SAMPLE CHARACTERISTICS: None of the patients had preoperative chemotherapy or radiation therapy.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Noninferiority randomized, controlled trial

Measurement Instruments/Methods

  • SSIs were recorded according to Centers for Disease Control (CDC) definitions for incision site and organ/space infections

Results

The incidence of incision site infections was 5% in the single-dose group and 7.1% in the multiple-dose group. Organ/space infections were 10.8% in the single-dose group and 8.6% in the multiple-dose group. Several organ/space infections were related to anastomotic dehiscence. Overall, the incidence of SSIs was 13.7% with single-dose prophylaxis and 13.6% with multiple-dose prophylaxis. Subgroup analysis by specific surgical procedure did not show any significant differences between groups.

Conclusions

Single-dose, postoperative, intravenous, antimicrobial prophylaxis demonstrated similar results to that of multiple-dose prophylaxis. Multiple antimicrobial doses did not show improved benefit for the prevention of surgical site infections

Limitations

  • Risk of bias (no blinding)

Nursing Implications

A single dose of IV antibiotic prophylaxis after rectal surgery for cancer had similar outcomes to that of multiple postoperative antibiotic doses. These findings show there is no benefit to more doses of prophylactic postoperative antibiotics for the prevention of SSIs.