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For Peer Review Only BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-011604 on 7 July 2016. Downloaded from Aqueous Versus Alcoholic Antisepsis with Chlorhexidine for Skin Excisions – The AVALANCHE Trial. Protocol for randomized controlled trial for the prevention of superficial surgical site infection after minor surgery in general For peer reviewpractice. only Journal: BMJ Open Manuscript ID bmjopen-2016-011604 Article Type: Protocol Date Submitted by the Author: 20-Feb-2016 Complete List of Authors: Heal, Clare; James Cook University, School of Medicine and Dentistry; Anton Breinl Research Centre for Health Systems Strengthening, Australian Institute of Tropical Health and Medicine Charles, Daniel; James Cook University, School of Medicine and Dentistry Hardy, Alexandra; James Cook University, School of Medicine and Dentistry Delpachitra, Meth; James Cook University, School of Medicine and Dentistry Banks, Jennifer; James Cook University, School of Medicine and Dentistry Wolfahrt, Michael; James Cook University, School of Medicine and Dentistry Buttner, Petra; James Cook University, School of Public Health, Tropical Medicine and Rehabilitation Sciences http://bmjopen.bmj.com/ <b>Primary Subject Public health Heading</b>: Secondary Subject Heading: Evidence based practice Keywords: PRIMARY CARE, WOUND MANAGEMENT, SURGERY on October 3, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 12 BMJ Open 1 BMJ Open: first published as 10.1136/bmjopen-2016-011604 on 7 July 2016. Downloaded from 2 3 TITLE 4 5 Aqueous Versus Alcoholic Antisepsis with Chlorhexidine for Skin Excisions – The 6 AVALANCHE Trial. Protocol for randomized controlled trial for the prevention of superficial 7 surgical site infection after minor surgery in general practice. 8 9 CF Heal1, 2, D Charles1, A Hardy1, M Delpachitra1, J Banks 1M Wohlfahrt1, P Buettner3 10 11 12 13 14 Corresponding Author 15 For peer review only 16 Professor Clare Heal 17 Promotional Chair 18 Discipline of General Practice and Rural Medicine 19 Mackay Clinical School 20 College of Medicine and Dentistry 21 James Cook University 22 Mackay Base Hospital, Bridge Rd 23 Mackay QLD 4740 Australia 24 [email protected] 25 26 Author Affiliations 27 28 1 Discipline of General Practice and Rural Medicine 29 Mackay Clinical School 30 College of Medicine and Dentistry 31 James Cook University 32 33 2 Anton Breinl Research Centre for Health Systems Strengthening, Australian Institute of http://bmjopen.bmj.com/ 34 35 Tropical Health and Medicine 36 3Tropical Health Solutions, Townsville, Qld and Centre for Chronic Disease Prevention, 37 James Cook University, Cairns, QLD 38 39 40 41 42 on October 3, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 12 1 BMJ Open: first published as 10.1136/bmjopen-2016-011604 on 7 July 2016. Downloaded from 2 3 4 ABSTRACT 5 6 Introduction: 7 Surgical site infection (SSI) after minor skin excisions has a significant impact on patient 8 morbidity and healthcare resources. Skin antisepsis prior to surgical incision is used to 9 10 prevent surgical site infection, and is performed routinely worldwide. However, in spite of the 11 routine use of skin antisepsis, there is no consensus regarding which antiseptic agents are 12 most effective. 13 14 Methods and analysis: 15 The study designFor is a prospective peer randomised review controlled trial (RCT)only with the aim of 16 investigating the impact of two different antiseptic preparations upon the incidence of 17 superficial surgical site infection in patients undergoing minor skin excisions. The 18 intervention of 0.5% chlorhexidine gluconate (CHG) in 70% alcohol will be compared with 19 0.5% chlorhexidine gluconate in aqueous solution. The trial will be conducted in four 20 Australian General Practices over a 9-month period, with 920 participants to be recruited. 21 Consecutive patients presenting for minor skin excisions will be eligible to participate. 22 Randomisation will be on the level of the patient. The primary outcome is superficial surgical 23 site infection in the first 30 days following the excision. Secondary outcomes will be adverse 24 effects including anaphylaxis, skin irritation, contact dermatitis and rash and patterns of 25 antibiotic resistance. 26 27 Ethics and Dissemination: The study has been approved by the James Cook University 28 Human Research Ethics Committee (HREC). Findings will be disseminated in conference 29 presentations and journals and through online electronic media. 30 31 Registration Details: The trial is registered with the Australian New Zealand Clinical Trials 32 Registry, registration number: ACTRN12615001045505. 33 34 http://bmjopen.bmj.com/ Discussion: RCTs conducted in General Practice differ from hospital based projects in 35 terms of feasibility, pragmatism and funding. The success of this trial will be cemented in 36 the fact that the research question was established by a group of GPs who identified an 37 interesting question which is relevant to their clinical practice and not answered by current 38 evidence. 39 40 41 42 on October 3, 2021 by guest. Protected copyright. Study Strengths 43 44 45 • Practical clinical question relevant to clinical practice 46 • Recruitment of clinicians and participants will be very feasible 47 • Independent outcome assessor will assess photographs of all infections 48 • Conduct of trial in General Practice will provide clinically relevant results to end user 49 50 Study Limitations 51 • Diagnosis of infection has element of subjectivity 52 • Practice based outcome assessors will not be blinded 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 12 BMJ Open 1 BMJ Open: first published as 10.1136/bmjopen-2016-011604 on 7 July 2016. Downloaded from 2 3 4 5 6 7 8 9 10 11 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41 42 on October 3, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 12 1 BMJ Open: first published as 10.1136/bmjopen-2016-011604 on 7 July 2016. Downloaded from 2 3 BACKGROUND 4 5 It is routine practice prior to surgery to carry out preoperative cleansing of the skin with 6 antiseptic preparations at the site of surgical incisions (preoperative skin antisepsis). [1-3] 7 The purpose of preoperative skin antisepsis is to reduce the incidence of surgical site 8 infection (SSI) by removing microorganisms on the skin through a combination of 9 mechanical removal and chemical killing. [1, 3, 4] The incidence of SSI arising from surgery 10 in general practice is usually 1-3%, but has been recorded at rates as high as 10%. [5-8] 11 The consequences of SSI include pain and discomfort for patients, increased healthcare- 12 associated costs and temporarily reduced occupational and recreational productivity and 13 functionality. [1, 3, 4, 9] As a result, reducing the incidence of SSIs is in the interest of all 14 stakeholders in healthcare. 15 For peer review only 16 The most commonly used preoperative skin antiseptic preparations are povidone iodine 17 (PVI) and chlorhexidine gluconate (CHG). Both are available in aqueous and alcoholic 18 preparations and in multiple different concentrations. [1, 3, 4] Both PVI and CHG are 19 effective against a wide range of gram positive and negative bacteria, viruses and fungi, 20 though CHG has a more appreciable residual antiseptic activity on the skin after application. 21 [1, 2, 4] 22 23 Surprisingly, despite the routine use of preoperative skin antisepsis, there is no definitive 24 scientific consensus regarding which antiseptic preparation is most effective at preventing 25 SSI. [1, 4, 9] There is even less definitive data available for antisepsis prior to clean surgery, 26 which the Centre for Disease Control (CDC) defines as “an uninfected operation in which no 27 inflammation is encountered and the respiratory, alimentary, genital or uninfected urinary 28 tract is not entered” (CDC, 2011). [10] Prior studies of wound infection after minor surgery in 29 General Practice in the Mackay region have shown a SSI rate of approximately 9.5% - an 30 incidence which is much higher than expected based on published results of similar cohorts 31 in other regions of Australia and the world. [11-14] The reason for this high infection rate is 32 unclear, but may be related to the hot, humid environment or to patient behaviour in our rural 33 setting. On one hand, this infection rate is suboptimal, as the CDC suggests that an http://bmjopen.bmj.com/ 34 35 acceptable rate of SSI after clean minor surgery is less than 5% [15]. However, in settings 36 where there is a low risk of infection after clean surgery, studies of over 5,000 procedures 37 may be required to detect a clinically relevant difference in infection from an intervention with 38 statistical confidence, making such trials unfeasible [16]. Conversely, because of the high 39 rate of infection in our patient cohort and the high minor surgery workload in rural general 40 practice [17], a study of skin antisepsis for the prevention of SSI in in our setting is highly 41 feasible. 42 on October 3, 2021 by guest. Protected copyright. 43 In general, the evidence base guiding appropriate selection of antiseptic agents is poor. A 44 landmark study found 2% CHG in 70% isopropyl alcohol to be superior to an aqueous 45 solution of 10% PVI, however, as alcohol is known to have significant antimicrobial 46 properties this was likely to be an active treatment component in in this study [18].
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