title: Surgical site infections following short-term radiotherapy and total mesorectal excision: results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery.
abstract: BACKGROUND
  Despite the findings of several randomized clinical studies, the role of gentamicin collagen implant (GCI) in rectal cancer surgery is unclear. Local pelvic application of GCI following preoperative radiotherapy and total mesorectal excision (TME) was evaluated to determine the risk of surgical site infections (SSI).
  
  
  METHODS
  In this single-center trial, 176 patients with rectal cancer after preoperative, short-term radiotherapy (5 × 5 Gy) were randomized either to the study group in which GCI was used or in the control group without GCI. Prior to surgery and intraoperatively five patients were excluded from the study. The remaining 171 patients were analyzed; 86 were in the study group and 85 in the control group.
  
  
  RESULTS
  There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group: 25.6 and 34.1 % respectively; p = 0.245, relative risk (RR) 0.750 [95 % confidence interval (CI) 0.471-1.195]. The reoperation rate was similar in both groups: 12.8 versus 9.4 %; p = 0.628; RR 1.359; (95 % CI 0.575-3.212). The total rate of SSI and organ space SSI were 22.2 and 15.8 % without differences between the study and control group. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received GCI: 2.6 versus 13.0 %; p = 0.018.
  
  
  CONCLUSIONS
  Application of GCI in the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.
authors.affiliation: Department of Oncological Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Centre, W. K. Roentgena 5, 02-781, Warsaw, Poland, az.rutkowski@onet.eu.
authors.forename: A
authors.initials: A
authors.lastname: Rutkowski
authors.forename: L
authors.initials: L
authors.lastname: Zając
authors.forename: L
authors.initials: L
authors.lastname: Pietrzak
authors.forename: M
authors.initials: M
authors.lastname: Bednarczyk
authors.forename: A
authors.initials: A
authors.lastname: Byszek
authors.forename: J
authors.initials: J
authors.lastname: Oledzki
authors.forename: T
authors.initials: T
authors.lastname: Olesiński
authors.forename: M
authors.initials: M
authors.lastname: Szpakowski
authors.forename: P
authors.initials: P
authors.lastname: Saramak
authors.forename: M
authors.initials: M
authors.lastname: Chwalinski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057868:Anastomotic Leak / Q000188:drug therapy / Q000517:prevention & control; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003094:Collagen / Q000008:administration & dosage; D003131:Combined Modality Therapy; D013505:Digestive System Surgical Procedures / Q000009:adverse effects / Q000379:methods; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000601:surgery; D012004:Rectal Neoplasms / Q000532:radiotherapy / Q000601:surgery*; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000150:complications / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D005839:Gentamicins; D003094:Collagen