title: Subcutaneous application of gentamicin collagen implants as prophylaxis of surgical site infections in laparoscopic colorectal surgery: a randomized, double-blinded, three-arm trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clinic for General, Visceral and Thorax Surgery, Marienhospital Stuttgart, Böheimstr. 37, 70199, Stuttgart, Germany, julius.pochhammer@vinzenz.de.
authors.forename: Julius
authors.initials: J
authors.lastname: Pochhammer
authors.forename: Steffi
authors.initials: S
authors.lastname: Zacheja
authors.forename: Michael
authors.initials: M
authors.lastname: Schäffer
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D019072:Antibiotic Prophylaxis; D003094:Collagen / Q000008:administration & dosage*; D003106:Colon / Q000601:surgery; D013505:Digestive System Surgical Procedures; D004311:Double-Blind Method; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D012007:Rectum / Q000601:surgery; D015503:Surgical Sponges; D013530:Surgical Wound Infection / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D005839:Gentamicins; D003094:Collagen