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

Abstract

BackgroundDesigning 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).MethodsThis was a prospective survey of dressings used to cover abdominal wounds. Surgical trainees from 25 hospitals were invited to participate. Information on patient risk factors, operation type and type of wound dressings used was recorded for elective and unplanned abdominal procedures over a 2‐week interval. The types of dressing used were summarized, and associations with operation type and patient risk factors explored.ResultsTwenty hospitals participated, providing data from 727 patients (1794 wounds). Wounds were predominantly covered with basic dressings (1203 of 1769, 68·0 per cent) and tissue adhesive was used in 27·4 per cent (485 of 1769); dressing type was missing for 25 wounds. Just 3·6 per cent of wounds (63 of 1769) 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 elective and unscheduled surgery.ConclusionBased 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.

Future direction of wound dressing research: Evidence From the bibliometric analysis

“…23 Table 1 illustrates the characteristics of 13 document types, including 5351 articles (84% of the 6397 documents) with the number of authors per publication ( APP ) of 5.6. The largest number of authors in the article is “Feasibility work to inform the design of a randomized clinical trial of wound dressings in elective and unplanned abdominal surgery” 24 published by 92 authors. The document type of the book chapters had the highest CPP 2020 of 112, which can be attributed to three highly cited book chapters with a TC 2020 of 100 or more, 19 by Reneker et al, 25 Muzzarelli and Muzzarelli, 26 and Klemm et al 27 with a TC 2020 of 498, 405, and 332, respectively.…”

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

“…Participants are randomised to one of three standard dressing groups: simple dressing (the comparator, believed to represent usual care [ 17 ]), no dressing or glue-as-a-dressing.…”

“…below skin level). A recent survey found that glue-as-a-dressing is a dressing strategy that is often used by general surgeons [ 17 ] but it is considered here as one of the two interventions, compared with a simple dressing (the comparator). Table 2 shows examples of commonly available tissue adhesives that can be used.…”

“…The Bluebelle study has two parts, Phase A and Phase B. Phase A comprised:case studies in general abdominal and obstetric surgery to understand and explore the current use of dressings and views about not using dressings [16];a survey of dressings currently used after primary wound closure [17];a review of the effectiveness and costs of dressings and contextual information (to update a Cochrane review [4]);development and validation of questionnaire tools to assess SSI after discharge [18] and practical wound management and participant symptom experience; [19]research to define metrics to measure the quality of wound closure and, through literature review, non-participant observations in theatres and interviews with surgeons;several meetings with people who had had surgery during Phase A to consider key aspects of the study and participants’ involvement, including information from participants’ interviews. …”

Impact of Surgihoney Reactive Oxygen on surgical site infection (SSI) after complex abdominal wall reconstruction (AWR) of grade 3 and 4 ventral Hernias: A single arm pilot study

“…A wound infection or surgical site infection (SSI) occurs in up to 40% of open abdominal operations [1]. It can increase the length of time a patient stays in hospital, increase patient dissatisfaction and litigation, and it may impair oncological outcomes.…”