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Randomized Controlled Trial
. 2017 Aug 29;18(1):401.
doi: 10.1186/s13063-017-2102-5.

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial

Bluebelle Study Group; Barnaby C Reeves  1 , Lazaros Andronis  2 , Jane M Blazeby  3   4 , Natalie S Blencowe  3   4 , Melanie Calvert  5   6 , Joanna Coast  3 , Tim Draycott  7 , Jenny L Donovan  3   8 , Rachael Gooberman-Hill  9 , Robert J Longman  4 , Laura Magill  10 , Jonathan M Mathers  6 , Thomas D Pinkney  10 , Chris A Rogers  11 , Leila Rooshenas  3 , Andrew Torrance  12 , Nicky J Welton  3 , Mark Woodward  4 , Kate Ashton  11 , Katarzyna D Bera  4 , Gemma L Clayton  3 , Lucy A Culliford  11 , Jo C Dumville  13 , Daisy Elliott  3 , Lucy Ellis  11 , Hannah Gould-Brown  3 , Rhiannon C Macefield  3 , Christel McMullan  10 , Caroline Pope  11 , Dimitrios Siassakos  7   11 , Sean Strong  3   4 , Helen Talbot  4
Affiliations
Randomized Controlled Trial

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial

Bluebelle Study Group et al. Trials. .

Abstract

Background: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered.

Methods/design: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial.

Discussion: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed.

Trial registration: ISRCTN49328913 . Registered on 20 October 2015.

Keywords: Abdominal surgery; Caesarean section; Feasibility study; Pilot study; Randomised controlled trial; Surgical site infection; Wound dressing.

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Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

Research ethics approval was granted by the South West–Frenchay REC (reference 15/SW/0008) in February 2015 and subsequently by the Health Research Authority (24 Aug 2016). We are obtaining written informed consent from all participants, in accordance with this approval. Two substantial amendments have been made to the protocol (8 December 2015; 6 September 2016). This approval covered all participating sites.

Consent for publication

The person who ‘modelled’ the skin transfer is not identifiable; nevertheless, she has consented to publication of the photograph shown in Fig. 3.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial schema. Schema showing the pathway for patients recruited into the Bluebelle Phase B external pilot trial, including the double randomisation
Fig. 2
Fig. 2
SPIRIT figure. The figure shows the phases of the trial and data collection time points
Fig. 3
Fig. 3
Skin transfers. Image shows a skin transfer applied near to the wound(s) to promote adherence to the randomised dressing allocation
See this image and copyright information in PMC

References

    1. The Royal College of Surgeons of England. From Theory to Theatre: Overcoming barriers to innovation in surgery. 2011. https://www.rcseng.ac.uk/library-and-publications/college-publications/d.... Accessed 20 June 2017.
    1. Merei JM. Pediatric clean surgical wounds: is dressing necessary? J Pediatr Surg. 2004;39(12):1871–3. doi: 10.1016/j.jpedsurg.2004.08.017. - DOI - PubMed
    1. Joint Formulary Committee et al. British National Formulary. London: BMJ Group and Pharmaceutical Press; 2014.
    1. Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, et al. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016;12:CD003091.
    1. Jenks PJ, Laurent M, McQuarry S, Watkins R. Clinical and economic burden of surgical site infection (SSI) and predicted financial consequences of elimination of SSI from an English hospital. J Hosp Infect. 2014;86(1):24–33. doi: 10.1016/j.jhin.2013.09.012. - DOI - PubMed

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