Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery.
BACKGROUND
Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges.


METHODS
In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin-collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments.


RESULTS
The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon's office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups.


CONCLUSIONS
Our large, multicenter trial shows that the gentamicin-collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections. (Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.)
Bennett-Guerrero
Elliott
E
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27710, USA. elliott.bennettguerrero@duke.edu
Pappas
Theodore N
TN
Koltun
Walter A
WA
Fleshman
James W
JW
Lin
Min
M
Garg
Jyotsna
J
Mark
Daniel B
DB
Marcet
Jorge E
JE
Remzi
Feza H
FH
George
Virgilio V
VV
Newland
Kerstin
K
Corey
G R
GR
D020341:Absorbable Implants; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D003082:Colectomy; D003094:Collagen; D015179:Colorectal Neoplasms / Q000601:surgery*; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage*; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012007:Rectum / Q000601:surgery; D015503:Surgical Sponges / Q000009:adverse effects; D013530:Surgical Wound Infection / Q000517:prevention & control*; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D005839:Gentamicins; D003094:Collagen