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Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

BMJ 2013; 347 doi: (Published 31 July 2013) Cite this as: BMJ 2013;347:f4305

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Re: Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

We thank the Professors Krukowski and Fadipe for their interest and comments regarding our trial. Regarding the enrolment of patients into ROSSINI, the CONSORT diagram (figure 2) displays the attrition rates of potentially eligible patients, and reasons for non-inclusion in the trial.
We agree that the overall SSI rate of 25% is higher than many would expect, but we are confident that it reflects true clinical practice. On reviewing all patients diagnosed with an SSI we found that as a group they had significantly longer initial length of stay in hospital, required greater resources in primary care (mean of 8 interactions with healthcare professionals versus 3.2) and lower levels of health-related quality of life compared to those not diagnosed with SSI. As for the other evidence in the same field, there remains a dearth of research utilising the necessary post-operative surveillance. The UK Surgical Site Infection Surveillance Service (SSISS) is a national public health programme that supports both the compulsory surveillance of SSI in orthopaedics (four categories) and voluntary surveillance in other categories of surgical procedures (13 categories). It obligates reporting of patients readmitted to hospital with SSI, but clinical wound reviews after discharge, or patient-reported questionnaires at 30 days remain optional. We feel that if clinicians or health providers are to establish their true rate of SSI, and certainly if they are taking steps to try and improve it, these active wound assessment measures must be undertaken or otherwise the traditional passive reporting will continue to result in a misleadingly low SSI rate.
Research in which these active assessments are performed almost universally identify a much higher rate of SSI.[1] To counteract any suggestion of ‘cherry-picking’ small studies, we would highlight the recently reported results from the VINcat program – a regional nosocomial infection surveillance program in Catalonia, Spain with excellent post-discharge follow-up.[2] Over their five year study period, 17,779 colorectal procedures were performed at 59 hospitals, with an overall SSI rate of 20.3%.

We agree that the prevention of SSI is not a uni-dimensional activity. This said, we designed a deliberately pragmatic trial to try to establish the ‘real-world’ efficacy of the devices as an adjunct to an otherwise normally undertaken operation. We specifically avoided a highly proscriptive trial with multiple non-standard interventions stipulated, as these trials are inherently harder to extrapolate from and so less likely to change practice.
Both correspondents question whether the pragmatic nature of the trial design may have masked an actual benefit from using the devices. As mentioned in the discussion we agree that it is possible that the devices might afford protection of the wound edges during the intra-abdominal phase of the operation, but the pathogens responsible for surgical site infection might then be introduced to the wound when the device is not in place—either on opening the wound before the device is inserted or on closing after the device has been removed. The latter would seem more likely.
Whilst the changing of gloves +/- instruments and drapes has been practised by some surgeons for several decades there is an absence of high-quality evidence supporting, or refuting, the role of these actions. It is not standard practice to changes gloves at the end of the intra-abdominal phase of a laparotomy in the UK (or other countries) at present.
We are currently in the late phases of designing a further major RCT in which several intra-operative adjuncts will be trialled (in a non-bundled design). Consideration is being given to a further evaluation of wound-edge protection devices, alongside an analysis of the impact of glove/instrument/drape changing on the efficacy of each and all interventions.
We hope that the ROSSINI trial has rekindled attention in the prevention of SSI after laparotomy, and hope that our ongoing research across this newly formed network of motivated units will reap rewards for patients and clinicians alike.

1)Leaper D, Tanner J, Kiernan M. Surveillance of surgical site infection: more accurate definitions and intensive recording needed. Journal of Hospital Infection 2013; 83:83-86.
2)Shaw E, Badia JM, Piriz M, Escofet R, Limon E, Gudiol F et al. What surgical site infection rates in colorectal surgery should be considered for benchmarking standards? Antimicrobial Resistance and Infection Control 2013; 9(s1):O53.

Competing interests: Authors of the original paper

24 August 2013
Thomas D Pinkney
Senior Lecturer and Consultant Colorectal Surgeon
West Midlands Research Collaborative and Academic Department of Surgery, University of Birmingham, UK
Room 29, 4th Floor Old Queen Elizabeth Hospital, Vincent Drive, Edgbaston, Birmingham, UK B15 2TH