M Kümin1, J Deery2, S Turney2, C Price2, P Vinayakam2, A Smith2, A Filippa3, L Wilkinson-Guy3, F Moore3, M O'Sullivan3, M Dunbar3, J Gaylard4, J Newman4, C M Harper5, D Minney6, C Parkin6, L Mew6, O Pearce6, K Third7, H Shirley7, M Reed7, L Jefferies8, J Hewitt-Gray8, C Scarborough8, D Lambert9, C I Jones9, S Bremner9, D Fatz4, N Perry4, M Costa10, M Scarborough11. 1. Nuffield Department of Medicine, University of Oxford, Oxford, UK. 2. East Kent Hospitals University NHS Foundation Trust, Canterbury, UK. 3. Heart of England NHS Foundation Trust, Birmingham, UK. 4. Brighton and Sussex University Hospitals NHS Trust, Brighton, UK. 5. Brighton and Sussex University Hospitals NHS Trust, Brighton, UK; Brighton and Sussex Medical School, Brighton, UK. 6. Milton Keynes University Hospitals NHS Foundation Trust, Milton Keynes, UK. 7. Northumbria Healthcare NHS Foundation Trust, Newcastle Upon Tyne, UK. 8. Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 9. Brighton and Sussex Medical School, Brighton, UK. 10. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 11. Oxford University Hospitals NHS Foundation Trust, Oxford, UK. Electronic address: 436461.Matthew.Scarborough@ouh.nhs.uk.
Abstract
BACKGROUND: Active warming during surgery prevents perioperative hypothermia but the effectiveness and postoperative infection rates may differ between warming technologies. AIM: To establish the recruitment and data management strategies needed for a full trial comparing postoperative infection rates associated with forced air warming (FAW) versus resistive fabric warming (RFW) in patients aged >65 years undergoing hemiarthroplasty following fractured neck of femur. METHODS: Participants were randomized 1:1 in permuted blocks to FAW or RFW. Hypothermia was defined as a temperature of <36°C at the end of surgery. Primary outcomes were the number of participants recruited and the number with definitive deep surgical site infections. FINDINGS:A total of 515 participants were randomized at six sites over a period of 18 months. Follow-up was completed for 70.1%. Thirty-seven participants were hypothermic (7.5% in the FAW group; 9.7% in the RFW group). The mean temperatures before anaesthesia and at the end of surgery were similar. For the primary clinical outcome, there were four deep surgical site infections in the FAW group and three in the RFW group. All participants who developed a postoperative infection had antibiotic prophylaxis, a cemented prosthesis, and were operated under laminar airflow; none was hypothermic. There were no serious adverse events related to warming. CONCLUSION:Surgical site infections were identified in both groups. Progression from the pilot to the full trial is possible but will need to take account of the high attrition rate.
RCT Entities:
BACKGROUND: Active warming during surgery prevents perioperative hypothermia but the effectiveness and postoperative infection rates may differ between warming technologies. AIM: To establish the recruitment and data management strategies needed for a full trial comparing postoperative infection rates associated with forced air warming (FAW) versus resistive fabric warming (RFW) in patients aged >65 years undergoing hemiarthroplasty following fractured neck of femur. METHODS:Participants were randomized 1:1 in permuted blocks to FAW or RFW. Hypothermia was defined as a temperature of <36°C at the end of surgery. Primary outcomes were the number of participants recruited and the number with definitive deep surgical site infections. FINDINGS: A total of 515 participants were randomized at six sites over a period of 18 months. Follow-up was completed for 70.1%. Thirty-seven participants were hypothermic (7.5% in the FAW group; 9.7% in the RFW group). The mean temperatures before anaesthesia and at the end of surgery were similar. For the primary clinical outcome, there were four deep surgical site infections in the FAW group and three in the RFW group. All participants who developed a postoperative infection had antibiotic prophylaxis, a cemented prosthesis, and were operated under laminar airflow; none was hypothermic. There were no serious adverse events related to warming. CONCLUSION: Surgical site infections were identified in both groups. Progression from the pilot to the full trial is possible but will need to take account of the high attrition rate.