TY - JOUR
T1 - 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)
T2 - study protocol for a randomised controlled trial
AU - Reeves, Barnaby C.
AU - Andronis, Lazaros
AU - Blazeby, Jane M
AU - Blencowe, Natalie S
AU - Calvert, Melanie
AU - Coast, Joanna
AU - Draycott, Tim
AU - Donovan, Jenny L
AU - Gooberman-Hill, Rachael
AU - Longman, Robert J
AU - Magill, Laura
AU - Mathers, Jonathan M
AU - Pinkney, Thomas D
AU - Rogers, Chris A
AU - Rooshenas, Leila
AU - Torrance, Andrew
AU - Welton, Nicky J
AU - Woodward, Mark
AU - Ashton, Kate
AU - Bera, Katarzyna D
AU - Clayton, Gemma L
AU - Culliford, Lucy A
AU - Dumville, Jo C
AU - Elliott, Daisy
AU - Ellis, Lucy
AU - Gould-Brown, Hannah
AU - Macefield, Rhiannon C
AU - McMullan, Christel
AU - Pope, Caroline
AU - Siassakos, Dimitrios
AU - Strong, Sean
AU - Talbot, Helen
AU - The Bluebelle Study Group
PY - 2017/8/29
Y1 - 2017/8/29
N2 - 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.
AB - 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.
KW - wound dressing
KW - Pilot study
KW - feasibility study
KW - randomised controlled trial
KW - Caesarean Section
KW - surgical site infection
KW - abdominal surgery
U2 - 10.1186/s13063-017-2102-5
DO - 10.1186/s13063-017-2102-5
M3 - Article
C2 - 28851399
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 401
ER -