Rutkowski, A., Zajac, L., Pietrzak, L., Bednarczyk, M., Byszek, A., Oledzki, J., . . . Chwalinski, M. (2014). Surgical site infections following short-term radiotherapy and total mesorectal excision: Results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery. Techniques in Coloproctology, 18, 921–928. 

To determine the risk of surgical site infection (SSI) reduction using local gentamicin collagen implants (GCIs) following preoperative radiotherapy and total mesorectal excisions (TMEs)

• Short-term radiotherapy (5 x 5 Gy) for rectal cancer preoperatively
• A GCI was inserted into the wound after surgical excision and prior to the closure of the cavity.

• N = 176   
• MEAN AGE = 63 years
• MALES: 63.3%, FEMALES: 32.7%
• CURRENT TREATMENT: Combination radiation and chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Rectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Preoperative radiation (XRT), then surgery within six days post XRT, but pushed out to 6–8 weeks if necessary

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Warsaw, Poland

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

• Randomized, controlled trial

• SSI definition included superficial and organ space infections as defined by the Centers for Disease Control and Prevention (CDC)
• Intrabdominal infections defined according to the Scottish Surveillance of Healthcare Associated Infection Program (e.g., cultures, abcesses, or other evidence of infection based on fever, symptoms, and diagnostic tests)

No statistically significant differences existed between the study and control groups in early postoperative complications (25.6% and 34.1%, respectively, p = 0.245). The reoperation rate was similar in both groups: 12.8% versus 9.4%, p = 0.628, risk ratio [RR] = 1.359, 95% confidence interval [CI] [0.575, 3.212]. The total rate of SSI and organ space SSI were 22.2% and 15.8% without differences between the study and control groups. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received the GCI: 2.6% versus 13%, p = 0.018.

Inconclusive: Applying the GCI in the pelvic cavity after short-term preoperative XRT and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.

Postoperative complications were a secondary aim and, therefore, the study lacked adequate power. Fewer patients received GCI because of a protocol deviation. Organ space SSI was not confirmed by bacteriological swabs. Sometimes, SSI was determined by a CT or physical symptoms and, therefore, could be misconstrued as infection when it was really an inflammatory reaction. This suggests that anastomotic leakage is such a significant risk factor for organ space SSI that the application of GCI does not prevent it. Patients were not given preoperative antibiotics, which is a current standard of care.

Nursing implications for this are clearly good surgical patient care postoperatively, such as using the aseptic technique while changing dressings; encouraging walking to prevent pneumonia; and teaching good nutrition for healing and excellent handwashing. The actual test depends on the surgeon’s suturing and excising techniques to prevent leakage. This study did not provide strong evidence for the use of CGIs to prevent SSIs.