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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.

Multi-centre randomised controlled trials (RCTs) in surgery are challenging. It is particularly difficult to establish standards of surgery and monitor whether interventions are delivered as intended. This can lead to uncertainties about the differences between trial group interventions and the meaning of observed treatment effects. This study developed and tested methods for intervention design and monitoring within the internal pilot phase of a surgical RCT.

Methods Two rounds of Delphi questionnaires were completed by patients and health professionals during the development of three surgical core sets. Participants rated items 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their stakeholder group only (single) or both stakeholder groups separately (dual). Items to retain following each round were determined by pre-specified criteria.