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

Autor: Rachael Gooberman-Hill, Mark Woodward, Helen Talbot, Kate Ashton, Chris A Rogers, Laura Magill, Lucy Ellis, Jonathan Mathers, Melanie Calvert, Tim Draycott, Rhiannon C Macefield, Leila Rooshenas, Joanna Coast, Natalie S Blencowe, Gemma L. Clayton, Dimitrios Siassakos, A. Torrance, Sean Strong, Jenny L Donovan, Thomas Pinkney, Daisy Elliott, Robert J Longman, Barnaby C Reeves, Jo C Dumville, Christel McMullan, Lucy Culliford, Hannah Gould-Brown, Nicky J Welton, Caroline Pope, Lazaros Andronis, Jane M Blazeby, Katarzyna D. Bera
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
Time Factors
medicine.medical_treatment
Surgical Wound
Psychological intervention
Medicine (miscellaneous)
Pilot Projects
030230 surgery
Feasibility study
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Abdomen
Medicine
Pharmacology (medical)
Caesarean section
030212 general & internal medicine
Randomised controlled trial
lcsh:R5-920
integumentary system
Surgical wound
3. Good health
Treatment Outcome
Research Design
Centre for Surgical Research
Wound dressing
Female
lcsh:Medicine (General)
Surgical site infection
medicine.medical_specialty
Blinding
Abdominal surgery
BTC (Bristol Trials Centre)
03 medical and health sciences
Humans
Surgical Wound Infection
Contraindication
Pilot study
Protocol (science)
Wound Healing
business.industry
Cesarean Section
Wound Closure Techniques
Bandages
United Kingdom
Economic evaluation
Physical therapy
Feasibility Studies
Tissue Adhesives
business
RD
Zdroj: Reeves, B, Andronis, L, Blazeby, J, Blencowe, N, Calvert, M, Coast, J, Draycott, T, Donovan, J, Gooberman-Hill, R, Longman, RJ, Magill, L, Mathers, J, Magill, L, Pinkney, T, Rogers, C, Rooshenas, L, Torrance, A, Welton, N, Woodward, M, Ashton, K, Bera, K, Clayton, G, Culliford, L, Dumville, J C, Elliott, D, Ellis, L, Gould Brown, H, Macefield, R, McMullan, C, Pope, C, Siassakos, D, Strong, S & Talbot, H 2017, ' 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 ', Trials, vol. 18, 401 . https://doi.org/10.1186/s13063-017-2102-5
Trials
Trials, Vol 18, Iss 1, Pp 1-12 (2017)
Reeves, B C, Andronis, L, Blazeby, J M, Blencowe, N S, Calvert, M, Coast, J, Draycott, T, Donovan, J L, Gooberman-Hill, R, Longman, R J, Magill, L, Mathers, J M, Pinkney, T D, Rogers, C A, Rooshenas, L, Torrance, A, Welton, N J, Woodward, M, Ashton, K, Bera, K D, Clayton, G L, Culliford, L A, Dumville, J C, Elliott, D, Ellis, L, Gould-Brown, H, Macefield, R C, McMullan, C, Pope, C, Siassakos, D, Strong, S, Talbot, H & The Bluebelle Study Group 2017, ' 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 ', Trials, vol. 18, no. 1, 401 . https://doi.org/10.1186/s13063-017-2102-5
ISSN: 4932-8913
1745-6215
DOI: 10.1186/s13063-017-2102-5
Popis: 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2102-5) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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