Bennett-Guerrero, E., Pappas, T.N., Koltun, W.A., Fleshman, J.W., Lin, M., Garg, J., . . . SWIPE 2 Trial Group. (2010). Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. New England Journal of Medicine, 363, 1038–1049.

The purpose of the study was to determine if an implantable gentamicin-collagen sponge prevents surgical infections in patients undergoing colorectal surgery.

Patients undergoing laparoscopic colorectal surgery in one of the 39 sites participating in the trial were randomized into either the sponge group or the control group after the surgical incision was made. If randomized into the experimental group, patients had a sponge (10 x 10 cm) implanted internally along their incision line just prior to the surgeon closing the wound that contained 280 mg of collagen and 130 mg of gentamicin. Both groups received standard of care of antibiotics 60 minutes prior to incision. Individuals who analyzed results were blinded to patient assignment.

• The sample included 602 participants.
• Ages ranged from 45–67 years.
• Males made up 56% of the sample; females made up 44%.
• Patients enrolled underwent surgery for colon or rectal cancer, diverticulitis, or inflammatory bowel disease.

Multiple sites

Multiple phases of care

Phase III blinded randomized, controlled trial

• ASEPSIS score through 60 days postoperatively    
• Serum creatinine peak reported for each patient for up to the first seven days postoperatively depending on discharge date
• Patient self-assessment of pain and wound healing 30 and 60 days postoperatively
• Data was recorded for any enrolled patients with visits to the emergency room, physician office, or readmission to the hospital with wound-related issues
• Serum gentamicin levels were obtained at baseline and up to 48 hours after wound closure
   

Surgical infections occurred more frequently in the sponge group with a rate of 30% as compared to the control group at 20%. Superficial site infections also were higher in the sponge group than the control group. The sponge group also was more likely to visit the emergency department or physician offices with wound-related complications (19% versus 11%).

The gentamicin collagen sponge is not effective in preventing surgical site infections in patient undergoing colorectal surgery.

The study did not determine if the sponge could be used to treat infection but, instead, focused only on infection prevention.

The gentamicin collagen sponge is not only not effective in preventing infection, but based on this study, may increase a patient’s risk for surgical wound infection.