Gentamicin-collagen sponges increased number of surgical site infections after colorectal cancer surgery

Bennett-Guerrero E. NEJM. 2010;doi:10.1056/NEJMoa1000837.

Insertion of a gentamicin-collagen sponge in patients who underwent surgery for colorectal cancer did not prevent surgical-site infection. In fact, more surgical-site infections were observed with use, according to new findings from a phase 3, multicenter trial.

Although prophylactic systemic antibiotics have been routinely used in patients undergoing colorectal surgery, surgical-site infection continues to be associated with significant morbidity and cost.

Therefore, researchers assessed the use of the gentamicin–collagen sponge (treatment arm; n=300) in comparison with no intervention (control arm; n=302) in patients who underwent open or laparoscopically assisted surgery for colorectal cancer across 39 U.S. sites.

Of those assigned to the treatment arm, 281 (93.7%), 15 (5%), and 4 (1.3%) received two, one, and no sponges, respectively. All patients received standard care, including prophylactic systemic antibiotics. Primary outcome measure was surgical-site infection within 60 days after surgery.

Three patients in the treatment arm and five patients in the control arm were lost to follow-up.

Surgical-site infection occurred in 30% of patients assigned gentamicin-collagen sponge insertion when compared with 20.9% of patients assigned to no intervention (P=.01).

Moreover, superficial surgical-site infection occurred in 20.3% of patients assigned to gentamicin-collagen sponge insertion vs. only 13.6% of controls (P=.03). Deep surgical-site infection occurred in 8.3% and 6%, respectively (P=.26).

Further, patients in the treatment arm were more likely to visit an emergency room or physician’s office due to wound-related signs or symptoms (19.7%, vs. 11% for controls; P=.004) and to be rehospitalized for surgical-site infection (7% vs. 4.3%, P=.15). Adverse events were similar between the two arms.

Possible limitations of the trial include the design of the trial — the prevention of infection — therefore, the results cannot address whether the sponge is effective for the treatment of infection. Secondly, the trial did not address the efficacy of sponge placement below the fascia, according to the researchers.

“Our large, multicenter trial shows that the gentamicin–collagen sponge is not effective at preventing surgical-site infection in patients undergoing colorectal surgery and, as compared with the placement of no sponges, appears to result in significantly more surgical site infections.” the researchers concluded.

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