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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: https://doi.org/10.1136/bmj.f4305 (Published 31 July 2013) Cite this as: BMJ 2013;347:f4305
  1. Thomas D Pinkney, senior lecturer and consultant colorectal surgeon12,
  2. Melanie Calvert, reader in epidemiology13,
  3. David C Bartlett, specialist registrar1,
  4. Adrian Gheorghe, doctoral researcher3,
  5. Val Redman, trial manager3,
  6. George Dowswell, research fellow13,
  7. William Hawkins, consultant upper gastrointestinal surgeon1,
  8. Tony Mak, assistant professor colorectal surgery1,
  9. Haney Youssef, consultant colorectal surgeon1,
  10. Caroline Richardson, specialist registrar1,
  11. Steven Hornby, specialist registrar1,
  12. Laura Magill, colorectal trial team leader14,
  13. Richard Haslop, trial manager3,
  14. Sue Wilson, professor of clinical epidemiology13,
  15. Dion Morton, professor of surgery124
  16. on behalf of the West Midlands Research Collaborative and the ROSSINI Trial Investigators
  1. 1West Midlands Research Collaborative, Old Queen Elizabeth Hospital, Edgbaston, Birmingham, UK
  2. 2Academic Department of Surgery, University of Birmingham, Birmingham, UK
  3. 3Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK
  4. 4Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK
  1. Correspondence to: TD Pinkney thomas.pinkney{at}uhb.nhs.uk
  • Accepted 27 June 2013

Abstract

Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

Design Multicentre observer blinded randomised controlled trial.

Participants Patients undergoing laparotomy at 21 UK hospitals.

Interventions Standard care or the use of a wound edge protection device during surgery.

Main outcome measures 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.

Trial registration Current Controlled Trials ISRCTN 40402832

Footnotes

  • ROSSINI Trial steering group

  • T Pinkney (chair), D Bartlett, T Mak, H Youseff, G Harrison, W Hawkins, D Morton, S Wilson, M Calvert, G Dowswell, V Redman, R Ryan, L Magill, J Bradbury, M Gill, L Berkman, D Leaper.

  • Data monitoring committee

  • J Dunn (chair), J Hill, A Obichere.

  • Trial administration and site support

  • J Bradbury, G Dowswell, M Ghods-Ghorbani, R Haslop, V Redman.

  • Statistical expertise

  • M Calvert, A Gheorghe, T Roberts.

  • West Midlands research collaborative committee

  • D Bartlett, A Bhangu, K Futaba, G Harrison, E Hepburn, S Macleod, T Mak, P Marriott, P Mistry, T Pinkney, H Youssef

  • Trials unit operations group

  • M Calvert (chair), G Dowswell, V Redman, R Haslop, S Warmington, A Gheorghe.

  • Local principle investigators

  • A Kingsnorth (Derriford Hospital, Plymouth); J Hardman (Good Hope Hospital, Sutton Coldfield); D Bowley (Heartlands Hospital, Birmingham); G Carlson (Hope Hospital, Manchester); S Selvaseter, A Khan (Leighton Hospital); A Hamouda (Maidstone Hospital); H Wegstapel (Medway Maritime Hospital); H Youssef (New Cross Hospital , Wolverhampton); S Clarke (Northwick Park, London); A Acheson (Queens Medical Centre, Nottingham); N Hurst (Royal Derby Hospital); P Boorman (Royal Devon and Exeter Hospital); R Patel (Russells Hall Hospital, Dudley); N Cruickshank (Sandwell Hospital); K Siddiqui (Tameside General Hospital, Manchester); R Pullan (Torbay Hospital); D Morton (University Hospital Birmingham); J Lengyel (University Hospital North Staffordshire); R Church (Walsall Manor Hospital); J Francombe (Warwick Hospital); M Paraoan (Wrightington, Wigan and Leigh).

  • Operating surgeons

  • S Aroori, M Bowles, S Brundell, A Kingsnorth, D Stell (Derriford Hospital, Plymouth); M Chapman, T Raju (Good Hope Hospital, Sutton Coldfield); D Bowley, C Hendrickse, S Karandikar, M Richardson, P Super (Heartlands Hospital, Birmingham); I Anderson, G Carlson, N Lees, D Speake, Jonathan Vickers, D Watson (Hope Hospital, Manchester); AU Khan, J Slavin (Leighton Hospital), S Bailey (Maidstone Hospital); S Andrews, W Garrett, P Gandhi, H Wegstapel (Medway Maritime Hospital); I Badger, F Curran, S Elgaddal, T Gardecki, B Isgar, M Manu, R Soulsby, GJ Williams, H Youssef (New Cross Hospital , Wolverhampton); S Clarke, I Jenkins, R Kennedy, R Phillips (Northwick Park, London); A Acheson, C Maxwell-Armstrong, J Simpson, J Willliams (Queens Medical Centre, Nottingham); N Hurst, S Y Iftikhar, M Larvin, J Lund, J Quarmby, J Reynolds, W Speake, G Tierney (Royal Derby Hospital); P Boorman, I Daniels, S Mansfield (Royal Devon and Exeter Hospital); A Jayatunga, A Kawesha, S Macleod, R Patel, R Pathak, A Rehman, A Savage, C Sellahewa, P Stonelake (Russells Hall Hospital, Dudley); N Cruickshank, K Gill, E Harper, H Joy, V Laloe, M Mirza, D Mobarak, M Sintler, V Thumbe, M Vairavan, K Wheatley (Sandwell Hospital); A Benhamida, K Siddiqui, M Solkar (Tameside General Hospital, Manchester); R Pullan (Torbay Hospital); O Adedeji, S Bach, D Gourevitch, T Ismail , C Keh, M Midwinter, D Morton, S Radley, N Suggett (University Hospital Birmingham), D Beardsmore, C Cheruvu, W Crisp, F Curran, R Dawson, M Deakin, D Durkin, M Farmer, R Kirby, J Lengyel (University Hospital North Staffordshire); R Church (Walsall Manor Hospital); K Busby, J Francombe, P Murphy, M Osborne (Warwick Hospital); A Azmi, A Blower, M Haque, R Harland, S Loganathan, N Mackenzie, M Paraoan (Wrightington, Wigan and Leigh).

  • Local investigators and wound reviewers

  • M Bowles, P Brockmann, F Coates, P Eardley, M Gavasingha, S Hornby, B Hyam, C Meachin, M Napier, A Page, S Price, S Read (Derriford Hospital, Plymouth); L Hanna, A Torrance, H Youssef (Good Hope Hospital, Sutton Coldfield); D Bowley, P Calderbank, W Hawkins, C Horrobin, A Munasinghe, S Nachrauthu, R Nandra (Heartlands Hospital, Birmingham); J Barker, E Barrow, C Downes, J Epstein, A Keen, V Shetty, D Speake, M Taylor (Hope Hospital, Manchester); V Adamson, C Hough, A Khan, C Mansfield, O Oshin (Leighton Hospital); J Bedo, R Einosas, A Hamouda, S Jones, L Tomlinson, A Wadoodi (Maidstone Hospital); T Akinola, R Casey, T Cumming, H Dent, R Evans (Medway Maritime Hospital); H Ali, S Ashraf, T AuYong, N Battersby, G Bonney, H Cheng, H Coop, H Cooper, S Dhanda, S Dhillon, S Elgaddal, C El-sayed Fi, M Green, J Long, G Markam, M Mascarentros, D McArthur, J Mohammed, S Pickering, T Pinkney, A Quigley, S Raichura, E Rahman, N Raza, C Richardson, S Roy, H Roberts, S Sahdev, T Sein, A Sharples, R Soulsby, M Treece, M Whitehouse, A Wong, H Youssef (New Cross Hospital , Wolverhampton); G Bashir, C Beaton, G Lee, G Rahbour, D Ramgoolam, S Rasheed, S Sakuma, S Sherman, C Thorn, S Wright (Northwick Park, London); E Barnes, D Humes, J Lynch, M Lythgoe, J Simpson, C Walter, K Ward (Queens Medical Centre, Nottingham); S Aggrawal, C Boereboom, E Collins, E Elsey, A Hall, S Hamandishe, L Kimber, O Peacock, S Pyke, D Reeves, J Smith, E Stobbs, N Watson (Royal Derby Hospital); S Harvey, R James, S Mansfield, Y Nijs, M Wiggins (Royal Devon andExeter Hospital); J Bate, A Bhangu, T Jennson, P Marriott, K McNamara, J Royle, P Singh, M Tan, J Walton, J Wheeler, L Wright, N Yassin (Russells Hall Hospital, Dudley); T Baldwin, M Ballentine, A Bhangu, C Bell, A Beveridge, J Carter, J Chrickshank, J Colley, D Cox, N Cruickshank, N Cutmore, J Dasgin, K Davis, M Dixon, J Doyle, A Dudley, G Fisher, H Fletcher, F Fuerstenberg, B Gammon, C Garbutt, K Goonetilleke, D Harji, H Harper, J Harvey, L Henderson, I Jenkins, A John, P Kaur, P Marriott, S Poxon, C Parkes, D Pugh, L Rhodes, K Richardson, M Roper, V Rusius, B Sharip, J Smith, S Todd, B Turner, D Vijayan, M Wakewal, R Walker, K Wheatley, L Williams (Sandwell Hospital); S Cocks, E Curran, S Ridgway (Tameside General Hospital, Manchester); B George, A Hall, P Mercer, H Thatcher, J Watson (Torbay Hospital); D Bartlett, S Baijal, J Bradbury, M Coakes, L Crutch, H Edgar, K Futaba, P Guruswamy, A Leyland, N Mabena, T Mak, K Manan, N Manimaran, N Markarian, R Melhado, J Millington, N Mirza, D Mittapalli, A Munasinghe, M Naqvi, S Pandey, T Pinkney, S Ramcharan, R Ravikumar, L Ryder, G Sahota, C Wearn, M White, K Wong (University Hospital Birmingham); S Bahia, D Beardsmore, C Bloom, N Briscoe, P Casey, S Dawson, M Deakin, M Denning, M Dennis, A Durber, M El-Shaeib, J Evans, L Fellows, S Hoswell, J Jackson, T Jones, M Lakhan, S Lord, W Hawkins, D Monnery, P Patel, F Rafati, M Reabin, E Rylands, O Sharifi, L Stevenson, F Tomlins (University Hospital North Staffordshire); R Church, A Kitchen, A Puligari, J Sidebotham, E Swan, A Tilley, L Wagstaff (Walsall Manor Hospital); J Barnes, L Clare, K Dasari, S Fallis, J Francombe, E Foster, K Futaba, E Leung, M McFarlane, S Rastall, N Silvey, G Waight, L Whisker (Warwick Hospital); M Antony, A Ahmed, S Baxendale, Y Chandler, M Corfield, Y Dunn, T Edwardson, N Fairclough, R Hodgkins, J Hughes, K Humayun, V Kaliyaperumal, S Lawton, J Leary, S Loganathan, N Mackenzie, M McDermott, M Paraoan, D Paterson, L Pender, P Prasad, J Smith, C Spence, L Roberts, A Robinson (Wrightington, Wigan and Leigh).

  • Funding: This study was funded by NIHR; Research for Patient Benefit programme (PB-PG-1208-18234). Wound edge protection devices were provided free of charge by 3M (Bracknell, UK), who also hosted the online e-learning module and quiz. Representatives from 3M did not sit on the trial management group and had no input in trial design, data collection, data analysis, or manuscript synthesis.

  • Contributors: TP, MC, DB, AG, GD, WH, TM, HY, LM, SW, and DM participated in the study design. HY, TP, TM, WH, LM, MC, DB, DL, SW, and DM obtained funding for the study. VR and RH collected the data. VR was trial manager. MC and AG analysed the data and provided methodological and statistical expertise. AG led the health economics analysis with support from MC, TR, TP and DB. TP, DM, MC, AG, and DB drafted the report, and the report was revised for important intellectual content by all authors. TP, MC, DB, AG, and DM are guarantors.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: The protocol16 was approved by the national research ethics service (09/H1204/91; North Staffordshire committee) and the research and development team at each hospital. Written informed consent was obtained from all patients before enrolment.

  • Data sharing: Statistical analysis plan and anonymised dataset available from to bona fide researchers on request from the corresponding author. A data transfer agreement will need to be completed. Consent was not obtained from participants for data sharing, but the presented data are anonymised and risk of identification is low.

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