Protocol for a randomised controlled trial comparing aqueous with alcoholic chlorhexidine antisepsis for the prevention of superficial surgical site infection after minor surgery in general practice: the AVALANCHE trial

Heal, C.F., Charles, D., Hardy, A., Delpachitra, M., Banks, J., Wohlfahrt, M., Saednia, Sabine, and Buettner, P. (2016) Protocol for a randomised controlled trial comparing aqueous with alcoholic chlorhexidine antisepsis for the prevention of superficial surgical site infection after minor surgery in general practice: the AVALANCHE trial. BMJ Open, 6 (7). e011614.

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Abstract

Introduction: Surgical site infection (SSI) after minor skin excisions has a significant impact on patient morbidity and healthcare resources. Skin antisepsis prior to surgical incision is used to prevent SSI, and is performed routinely worldwide. However, in spite of the routine use of skin antisepsis, there is no consensus regarding which antiseptic agents are most effective. The AVALANCHE trial will compare Aqueous Versus Alcoholic Antisepsis with Chlorhexidine for Skin Excisions.

Methods and analysis: The study design is a prospective, randomised controlled trial (RCT) with the aim of investigating the impact of two different antiseptic preparations on the incidence of superficial SSI in patients undergoing minor skin excisions. The intervention of 0.5% chlorhexidine gluconate (CHG) in 70% alcohol will be compared with that of 0.5% CHG in aqueous solution. The trial will be conducted in four Australian general practices over a 9-month period, with 920 participants to be recruited. Consecutive patients presenting for minor skin excisions will be eligible to participate. Randomisation will be on the level of the patient. The primary outcome is superficial SSI in the first 30 days following the excision. Secondary outcomes will be adverse effects, including anaphylaxis, skin irritation, contact dermatitis and rash and patterns of antibiotic resistance.

Ethics and dissemination: The study has been approved by the James Cook University Human Research Ethics Committee (HREC). Findings will be disseminated in conference presentations and journals and through online electronic media.

Discussion: RCTs conducted in general practice differ from hospital-based projects in terms of feasibility, pragmatism and funding. The success of this trial will be cemented in the fact that the research question was established by a group of general practitioners who identified an interesting question which is relevant to their clinical practice and not answered by current evidence.

Item ID: 44605
Item Type: Article (Research - C1)
ISSN: 2044-6055
Keywords: primary care, wound management, surgery
Additional Information:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.

Funders: James Cook University (JCU), Royal Australian College of General Practitioners (RACGP)
Projects and Grants: RACGP PWH Grieve Award, FACGP Family Medical Care Education and Research Grant, JCU Honours programme grant
Date Deposited: 25 Jul 2016 22:27
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111717 Primary Health Care @ 100%
SEO Codes: 92 HEALTH > 9204 Public Health (excl. Specific Population Health) > 920412 Preventive Medicine @ 100%
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