title: Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial).
abstract: OBJECTIVE
  To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.
  
  
  METHODS
  Multicentre observer blinded randomised controlled trial.
  
  
  METHODS
  Patients undergoing laparotomy at 21 UK hospitals.
  
  
  METHODS
  Standard care or the use of a wound edge protection device during surgery.
  
  
  METHODS
  Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient's self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.
  
  
  RESULTS
  760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.
  
  
  CONCLUSIONS
  Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 40402832.
authors.affiliation: West Midlands Research Collaborative, Old Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Pinkney
authors.forename: Melanie
authors.initials: M
authors.lastname: Calvert
authors.forename: David C
authors.initials: DC
authors.lastname: Bartlett
authors.forename: Adrian
authors.initials: A
authors.lastname: Gheorghe
authors.forename: Val
authors.initials: V
authors.lastname: Redman
authors.forename: George
authors.initials: G
authors.lastname: Dowswell
authors.forename: William
authors.initials: W
authors.lastname: Hawkins
authors.forename: Tony
authors.initials: T
authors.lastname: Mak
authors.forename: Haney
authors.initials: H
authors.lastname: Youssef
authors.forename: Caroline
authors.initials: C
authors.lastname: Richardson
authors.forename: Steven
authors.initials: S
authors.lastname: Hornby
authors.forename: Laura
authors.initials: L
authors.lastname: Magill
authors.forename: Richard
authors.initials: R
authors.lastname: Haslop
authors.forename: Sue
authors.initials: S
authors.lastname: Wilson
authors.forename: Dion
authors.initials: D
authors.lastname: Morton
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000368:Aged; D016001:Confidence Intervals; D006801:Humans; D007902:Length of Stay; D008875:Middle Aged; D016017:Odds Ratio; D010969:Plastics; D011788:Quality of Life; D016037:Single-Blind Method; D058636:Surgical Drapes; D013530:Surgical Wound Infection / Q000517:prevention & control*
chemical_list: D010969:Plastics
references.citation: J Trauma. 2007 Jan;62(1):212-5
references.pmid: 17215757
references.citation: Emerg Infect Dis. 2003 Feb;9(2):196-203
references.pmid: 12603990
references.citation: Ann Surg. 2012 Jun;255(6):1030-1
references.pmid: 22549753
references.citation: Trials. 2011 Oct 04;12:217
references.pmid: 21970469
references.citation: J Hosp Infect. 2005 Jun;60(2):93-103
references.pmid: 15866006
references.citation: Health Policy. 1996 Jul;37(1):53-72
references.pmid: 10158943
references.citation: Dis Colon Rectum. 2001 Aug;44(8):1100-5
references.pmid: 11535848
references.citation: Br J Surg. 1998 Sep;85(9):1232-41
references.pmid: 9752867
references.citation: BMC Infect Dis. 2006 Nov 27;6:170
references.pmid: 17129368
references.citation: Surgery. 2007 Nov;142(5):704-11
references.pmid: 17981191
references.citation: Ann Surg. 2012 Jun;255(6):1017-29
references.pmid: 22270692
references.citation: BMJ. 2004 Sep 25;329(7468):720
references.pmid: 15367425
references.citation: J Hosp Infect. 2008 Jul;69(3):230-48
references.pmid: 18550218
references.citation: J Hosp Infect. 2001 Mar;47(3):198-209
references.pmid: 11247680
references.citation: Arch Surg. 2011 May;146(5):606-12
references.pmid: 21576613
references.citation: Colorectal Dis. 2012 Jun;14(6):e346-51
references.pmid: 22568647
references.citation: Am J Infect Control. 1995 Oct;23(5):290-4
references.pmid: 8585640
references.citation: Colorectal Dis. 2010 May;12(5):423-7
references.pmid: 19243392
references.citation: Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80
references.pmid: 10219875
references.citation: Clin Exp Obstet Gynecol. 2011;38(1):57-9
references.pmid: 21485728
references.citation: Lancet. 1999 May 8;353(9164):1585
references.pmid: 10334259
references.citation: Dis Colon Rectum. 1984 Jul;27(7):451-3
references.pmid: 6378555
references.citation: Health Technol Assess. 2001;5(22):1-194
references.pmid: 11532239
references.citation: Surg Infect (Larchmt). 2010 Dec;11(6):501-3
references.pmid: 20849290
references.citation: Am J Infect Control. 2008 Jun;36(5):309-32
references.pmid: 18538699
references.citation: J Hosp Infect. 2009 Jul;72(3):243-50
references.pmid: 19446918
references.citation: Dis Colon Rectum. 2010 Oct;53(10):1374-80
references.pmid: 20847618
references.citation: Med Care. 1997 Nov;35(11):1095-108
references.pmid: 9366889
references.citation: Ann Surg. 2012 Jul;256(1):53-9
references.pmid: 22584694