Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds
| Autor: | Samir Pathak, Barnaby Reeves, Jane Blazeby, Madeleine Clout, Kathryn Lee, Thomas Pinkney, Natalie Blencowe, Lazaros Andronis, James Glasbey, Laura Magill, Piriyankan Ananthavarathan, Melanie Calvert, Joanna Coast, Vijay Korwar, Benjamin R. Waterhouse |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Cost-Benefit Analysis Psychological intervention Pilot Projects 030501 epidemiology wound dressing law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life RZ law medicine Humans Surgical Wound Infection 030212 general & internal medicine Trial registration Aged Wound Healing integumentary system business.industry tissue adhesive as a dressing Incidence pilot study Surgical wound General Medicine Middle Aged surgical site infection Bandages United Kingdom 3. Good health Wound dressing Practice Guidelines as Topic Quality of Life Physical therapy Feasibility Studies Surgery Female 0305 other medical science business human activities Surgical site infection randomised controlled trial Abdominal surgery |
| Zdroj: | Blazeby, J M & Blencowe, N S 2020, ' Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds ', BMJ Open, vol. 10, no. 1, e030615 . https://doi.org/10.1136/bmjopen-2019-030615 BMJ Open |
| ISSN: | 4932-8913 2044-6055 |
| DOI: | 10.1136/bmjopen-2019-030615 |
| Popis: | ObjectiveSurgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.DesignA pilot, factorial RCT.SettingFive UK hospitals.ParticipantsAdults undergoing abdominal surgery with a primary surgical wound.InterventionsParticipants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).Primary and secondary outcome measuresFeasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).ResultsBetween March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks.ConclusionsA definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.Trial registration number49328913; Pre-results. |
| Databáze: | OpenAIRE |
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