The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Mark Woodward; Nicky J Welton; Benjamin R Waterhouse; Andrew D  Torrance; Sean Strong; Dimitrios  Siassakos; William  Seligman; Leila Rooshenas; Chris Rogers; Lloyd  Rickard; Barnaby C Reeves; Anne M Pullyblank; Caroline Pope; Thomas Pinkney; Samir  Pathak; Anwar  Owais; Jamie  O’Callaghan; Stephen  O’Brien; Dmitri Nepogodiev; Khaldoun  Nadi; Charlotte E  Murkin; Tonia  Munder; Tom  Milne; David E Messenger; Christel McMullan; Jonathan Mathers; Matthew  Mason; Morwena  Marshall; Rhiannon Macefield; Richard  Lovegrove; Robert J Longman; Jessica  Lloyd; Jeffrey  Lim; Kathryn  Lee; Vijay  Korwar; Daniel  Hughes; George  Hill; Rosie  Harris; Mohammed  Hamdan; Hannah Gould-Brown; Rachael Gooberman-Hill; James Glasbey; Caroline  Fryer; Daisy Elliott; Jo C Dumville; Tim Draycott; Jenny L. Donovan; Simon  Davey; David  Cotton; Joanna  Coast; Madeleine  Clout; Melanie Calvert; Benjamin E  Byrne; Oliver D  Brown; Jane M Blazeby; Natalie S Blencowe; Katarzyna D. Bera; Joanne  Bennett; Richard Bamford; Danya  Bakhbakhi; Muhammad Atif; Kate Ashton; Elizabeth  Armstrong; Lazaros Andronis; Piriyankan  Ananthavarathan

The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Mark Woodward, Nicky J Welton, Benjamin R Waterhouse, Andrew D Torrance, Sean Strong, Dimitrios Siassakos , William Seligman, Leila Rooshenas, Chris Rogers, Lloyd Rickard, Barnaby C Reeves, Anne M Pullyblank, Caroline Pope, Thomas Pinkney, Samir Pathak, Anwar Owais, Jamie O’Callaghan, Stephen O’Brien, Dmitri Nepogodiev, Khaldoun NadiCharlotte E Murkin, Tonia Munder, Tom Milne, David E Messenger, Christel McMullan, Jonathan Mathers, Matthew Mason, Morwena Marshall, Rhiannon Macefield, Richard Lovegrove, Robert J Longman, Jessica Lloyd, Jeffrey Lim, Kathryn Lee, Vijay Korwar, Daniel Hughes, George Hill, Rosie Harris, Mohammed Hamdan, Hannah Gould-Brown, Rachael Gooberman-Hill, James Glasbey, Caroline Fryer, Daisy Elliott, Jo C Dumville, Tim Draycott, Jenny L. Donovan, Simon Davey, David Cotton, Joanna Coast, Madeleine Clout, Melanie Calvert, Benjamin E Byrne, Oliver D Brown, Jane M Blazeby, Natalie S Blencowe, Katarzyna D. Bera, Joanne Bennett, Richard Bamford, Danya Bakhbakhi, Muhammad Atif, Kate Ashton, Elizabeth Armstrong, Lazaros Andronis, Piriyankan Ananthavarathan

Research output: Contribution to journal › Article › peer-review

Abstract

Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design: A pilot, factorial randomised controlled trial (RCT). Setting: Five UK hospitals. Participants: Adults undergoing abdominal surgery with a primary surgical wound. Interventions: Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant- and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results: Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133; glue=129; ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132) respectively. Adherence to disclosure time was 99% and 86% before and after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the WHQ and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks. Conclusions: A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.

Original language	English
Journal	BMJ open
Publication status	Accepted/In press - 11 Nov 2019

Keywords

Randomised controlled trial
Pilot study
Surgical site infection
Wound dressing
Tissue adhesive as a dressing

Cite this

Woodward, M., Welton, N. J., Waterhouse, B. R., Torrance, A. D., Strong, S., Siassakos , D., Seligman, W., Rooshenas, L., Rogers, C., Rickard, L., Reeves, B. C., Pullyblank, A. M., Pope, C., Pinkney, T., Pathak, S., Owais, A., O’Callaghan, J., O’Brien, S., Nepogodiev, D., ... Ananthavarathan, P. (Accepted/In press). The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds. BMJ open.

@article{7f1cb12c297043efaad13d57e527ba4a,

title = "The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds",

abstract = "Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design: A pilot, factorial randomised controlled trial (RCT). Setting: Five UK hospitals. Participants: Adults undergoing abdominal surgery with a primary surgical wound. Interventions: Participants were randomised to {\textquoteleft}simple dressing{\textquoteright}, {\textquoteleft}glue-as-a-dressing{\textquoteright} or {\textquoteleft}no dressing{\textquoteright}, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant- and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results: Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133; glue=129; {\textquoteleft}no dressing{\textquoteright}=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132) respectively. Adherence to disclosure time was 99% and 86% before and after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the WHQ and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks. Conclusions: A definitive RCT of dressing strategies including {\textquoteleft}no dressing{\textquoteright} is feasible. Further work is needed to optimise questionnaire response rates.",

keywords = "Randomised controlled trial, Pilot study, Surgical site infection, Wound dressing, Tissue adhesive as a dressing",

author = "Mark Woodward and Welton, {Nicky J} and Waterhouse, {Benjamin R} and Torrance, {Andrew D} and Sean Strong and Dimitrios Siassakos and William Seligman and Leila Rooshenas and Chris Rogers and Lloyd Rickard and Reeves, {Barnaby C} and Pullyblank, {Anne M} and Caroline Pope and Thomas Pinkney and Samir Pathak and Anwar Owais and Jamie O{\textquoteright}Callaghan and Stephen O{\textquoteright}Brien and Dmitri Nepogodiev and Khaldoun Nadi and Murkin, {Charlotte E} and Tonia Munder and Tom Milne and Messenger, {David E} and Christel McMullan and Jonathan Mathers and Matthew Mason and Morwena Marshall and Rhiannon Macefield and Richard Lovegrove and Longman, {Robert J} and Jessica Lloyd and Jeffrey Lim and Kathryn Lee and Vijay Korwar and Daniel Hughes and George Hill and Rosie Harris and Mohammed Hamdan and Hannah Gould-Brown and Rachael Gooberman-Hill and James Glasbey and Caroline Fryer and Daisy Elliott and Dumville, {Jo C} and Tim Draycott and Donovan, {Jenny L.} and Simon Davey and David Cotton and Joanna Coast and Madeleine Clout and Melanie Calvert and Byrne, {Benjamin E} and Brown, {Oliver D} and Blazeby, {Jane M} and Blencowe, {Natalie S} and Bera, {Katarzyna D.} and Joanne Bennett and Richard Bamford and Danya Bakhbakhi and Muhammad Atif and Kate Ashton and Elizabeth Armstrong and Lazaros Andronis and Piriyankan Ananthavarathan",

year = "2019",

month = nov,

day = "11",

language = "English",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

}

Woodward, M, Welton, NJ, Waterhouse, BR, Torrance, AD, Strong, S, Siassakos , D, Seligman, W, Rooshenas, L, Rogers, C, Rickard, L, Reeves, BC, Pullyblank, AM, Pope, C, Pinkney, T, Pathak, S, Owais, A, O’Callaghan, J, O’Brien, S, Nepogodiev, D, Nadi, K, Murkin, CE, Munder, T, Milne, T, Messenger, DE, McMullan, C , Mathers, J, Mason, M, Marshall, M, Macefield, R, Lovegrove, R, Longman, RJ, Lloyd, J, Lim, J, Lee, K, Korwar, V, Hughes, D, Hill, G, Harris, R, Hamdan, M, Gould-Brown, H, Gooberman-Hill, R, Glasbey, J, Fryer, C, Elliott, D, Dumville, JC, Draycott, T, Donovan, JL, Davey, S, Cotton, D, Coast, J, Clout, M, Calvert, M, Byrne, BE, Brown, OD, Blazeby, JM, Blencowe, NS, Bera, KD, Bennett, J, Bamford, R, Bakhbakhi, D, Atif, M, Ashton, K, Armstrong, E, Andronis, L & Ananthavarathan, P 2019, 'The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds', BMJ open.

TY - JOUR

T1 - The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

AU - Woodward, Mark

AU - Welton, Nicky J

AU - Waterhouse, Benjamin R

AU - Torrance, Andrew D

AU - Strong, Sean

AU - Siassakos , Dimitrios

AU - Seligman, William

AU - Rooshenas, Leila

AU - Rogers, Chris

AU - Rickard, Lloyd

AU - Reeves, Barnaby C

AU - Pullyblank, Anne M

AU - Pope, Caroline

AU - Pinkney, Thomas

AU - Pathak, Samir

AU - Owais, Anwar

AU - O’Callaghan, Jamie

AU - O’Brien, Stephen

AU - Nepogodiev, Dmitri

AU - Nadi, Khaldoun

AU - Murkin, Charlotte E

AU - Munder, Tonia

AU - Milne, Tom

AU - Messenger, David E

AU - McMullan, Christel

AU - Mathers, Jonathan

AU - Mason, Matthew

AU - Marshall, Morwena

AU - Macefield, Rhiannon

AU - Lovegrove, Richard

AU - Longman, Robert J

AU - Lloyd, Jessica

AU - Lim, Jeffrey

AU - Lee, Kathryn

AU - Korwar, Vijay

AU - Hughes, Daniel

AU - Hill, George

AU - Harris, Rosie

AU - Hamdan, Mohammed

AU - Gould-Brown, Hannah

AU - Gooberman-Hill, Rachael

AU - Glasbey, James

AU - Fryer, Caroline

AU - Elliott, Daisy

AU - Dumville, Jo C

AU - Draycott, Tim

AU - Donovan, Jenny L.

AU - Davey, Simon

AU - Cotton, David

AU - Coast, Joanna

AU - Clout, Madeleine

AU - Calvert, Melanie

AU - Byrne, Benjamin E

AU - Brown, Oliver D

AU - Blazeby, Jane M

AU - Blencowe, Natalie S

AU - Bera, Katarzyna D.

AU - Bennett, Joanne

AU - Bamford, Richard

AU - Bakhbakhi, Danya

AU - Atif, Muhammad

AU - Ashton, Kate

AU - Armstrong, Elizabeth

AU - Andronis, Lazaros

AU - Ananthavarathan, Piriyankan

PY - 2019/11/11

Y1 - 2019/11/11

N2 - Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design: A pilot, factorial randomised controlled trial (RCT). Setting: Five UK hospitals. Participants: Adults undergoing abdominal surgery with a primary surgical wound. Interventions: Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant- and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results: Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133; glue=129; ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132) respectively. Adherence to disclosure time was 99% and 86% before and after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the WHQ and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks. Conclusions: A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.

AB - Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design: A pilot, factorial randomised controlled trial (RCT). Setting: Five UK hospitals. Participants: Adults undergoing abdominal surgery with a primary surgical wound. Interventions: Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant- and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results: Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133; glue=129; ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132) respectively. Adherence to disclosure time was 99% and 86% before and after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the WHQ and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks. Conclusions: A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.

KW - Randomised controlled trial

KW - Pilot study

KW - Surgical site infection

KW - Wound dressing

KW - Tissue adhesive as a dressing

M3 - Article

SN - 2044-6055

JO - BMJ open

JF - BMJ open

ER -

The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Abstract

Keywords

Fingerprint

Cite this