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.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Bluebelle Study Group, Reeves Barnaby C, Andronis Lazaros, Blazeby Jane M, Blencowe Natalie S, Calvert Melanie, Coast Joanna, Draycott Tim, Donovan Jenny L, Gooberman-Hill Rachael, Longman Robert J, Magill Laura, Mathers Jonathan M, Pinkney Thomas D, Rogers Chris A, Rooshenas Leila, Torrance Andrew, Welton Nicky J, Woodward Mark, Ashton Kate, Bera Katarzyna D, Clayton Gemma L, Culliford Lucy A, Dumville Jo C, Elliott Daisy, Ellis Lucy, Gould-Brown Hannah, Macefield Rhiannon C, McMullan Christel, Pope Caroline, Siassakos Dimitrios, Strong Sean, Talbot Helen
Аннотация
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.