Feasibility work to inform the design of a randomized clinical trial of wound dressings in elective and unplanned abdominal surgery

Severn and Peninsula Audit and Research Collaborative for Surgeons (SPARCS), West Midlands Research Collaborative (WMRC), The Bluebelle Study Group, Natalie Blencowe, Jane Blazeby, Jenny Donovan, Leila Rooshenas, Daisy Elliott, Rhiannon Macefield, Chris Rogers, Helen Van Der Nelson, Mark Woodward, Gemma Clayton, Lucy Ellis, Robert Longman, Joanna Coast, Sean Strong, Dimitrios Siassakos, Cathy Winter, Timothy DraycottRachael Gooberman-Hill, Barnaby Reeves, Helen Talbot

Research output: Contribution to journalArticle (Academic Journal)

8 Citations (Scopus)
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Abstract

Background: Designing randomized controlled trials (RCTs) in surgery requires consideration of existing evidence, stakeholders’ views and emerging interventions, to ensure that research questions are relevant to patients, surgeons and the health service. When there is uncertainty about RCT design, feasibility work is recommended. This study aimed to assess how feasibility work could inform the design of a future pilot study and RCT (Bluebelle, HTA-12/200/04).

Methods: A prospective survey of dressings used to cover abdominal wounds was undertaken. Surgical trainees from 25 hospitals were invited to participate. Information about patient risk factors, operation type and type of wound dressings used were recorded for elective and unplanned abdominal procedures over a two week period. The type of dressings used were summarized and associations with operation type and patient risk factors explored.

Results: Twenty hospitals participated, providing data from 727 patients (1794 wounds). Wounds were predominantly covered with basic dressings (n=1203/1769, 68%) and in 27% (485/1769), tissue adhesive was used; dressing type was missing for 25 wounds. Just 4% (63/1769) wounds did not have a dressing applied at the end of the procedure. There was no evidence of an association between type of dressing used and patient risk factors, type of operation, or between elective and unscheduled surgery.

Conclusions: Based on the findings from this large study of current practice, the pilot study design has evolved. The inclusion criteria have expanded to encompass patients undergoing unscheduled surgery, and tissue adhesive as-a-dressing will be evaluated as an additional intervention group. Collaborative methods are recommended to inform the design of RCTs in surgery, helping to ensure they are relevant to current practice.
Original languageEnglish
Pages (from-to)1738-1744
Number of pages7
JournalBritish Journal of Surgery
Volume103
Issue number12
Early online date4 Aug 2016
DOIs
Publication statusPublished - 1 Nov 2016

Structured keywords

  • ConDuCT-II
  • Centre for Surgical Research
  • BTC (Bristol Trials Centre)

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