Abstract
BackgroundSurgical 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/DesignThis 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.DiscussionThis 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 registrationISRCTN49328913. Registered on 20 October 2015.
Highlights
Evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants
The clinical team may apply any dressing to the wound; where this represents deviation from the allocated dressing, the action is documented in the case report forms (CRFs); Co-interventions that may influence surgical site infection (SSI) rates will be allowed at the discretion of the team and hospital looking after the participants
The design of pilot trial depended on the findings of Phase A and the design was finalised shortly before starting to recruit
Summary
The short duration of the pilot trial, constrained by the length of the overall research contract, has been a challenge. The time constraints for the overall study (both Phase A and Phase B), combined with the time needed to obtain REC approval, made it inevitable that an amendment would be required after Phase A ended This amendment included: changing the trial population to include patients having unplanned operations; substituting the intervention of a complex dressing with glue-asa-dressing; and addition of the WMQ and WEQ as secondary outcomes. The need for a second amendment (v3 to v4, to v5 to accommodate a change requested by the REC) arose from initial difficulties in recruiting patients having unplanned surgery and obtaining patient-reported follow-up questionnaires This amendment (approved 6 September 2016) substituted a 4-h period between giving the PIL to a potential participant and requesting consent by the statement ‘as long as possible,’ qualifying this as ‘usually more than 4 hours for elective surgery and usually more than 1 hour for unplanned surgery’.
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