Subcutaneous application of gentamicin collagen implants as prophylaxis of surgical site infections in laparoscopic colorectal surgery: a randomized, double-blinded, three-arm trial.

Abstract

Despite a standardized prophylaxis with antibiotics, surgical site infections (SSI) are a characteristic problem in colorectal surgery. Local administration of gentamicin-collagen sponges (GCS) has been shown to decrease the infection rate after contaminated procedures. So far, the effect has not been tested for standardized laparoscopic colorectal resections. We conducted a randomized, double-blind, placebo-controlled trial to investigate the efficacy of GCS to reduce wound infection after laparoscopic colorectal resections. Patients underwent a standardized operative procedure with standardized incision treatment. The intervention was the application of a GCS in the subcutaneous tissue of the bowel extraction site (GCS group). In the collagen group, a collagen sponge without antibiotics was used, and no sponge was used in the control group. The primary endpoint was SSI within 30 days postoperatively, according to the Center of Disease Control and Prevention definition. We randomly assigned 291 patients to all three groups. There was no difference between the groups regarding demographic characteristics and perioperative course. SSI was diagnosed in 8.2 % (GCS group), 13.5 % (collagen group), and 11.3 % (control group) of patients. No significant difference was found among the groups. The local administration of GCS showed no significant benefit regarding wound infection after standardized laparoscopic colorectal resections. However, there was a trend toward reduced SSI in the GCS group. Therefore, a larger trial or meta-analysis is necessary to validate this result.