title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ACTRN12615001045505; Pre-results.
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia Anton Breinl Research Centre for Health Systems Strengthening, Australian Institute of Tropical Health and Medicine, Townsville, Queensland, Australia.
authors.forename: C F
authors.initials: CF
authors.lastname: Heal
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Charles
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Hardy
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Delpachitra
authors.forename: J
authors.initials: J
authors.lastname: Banks
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Wohlfahrt
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.
authors.forename: Sabine
authors.initials: S
authors.lastname: Saednia
authors.affiliation: Discipline of General Practice and Rural Medicine, Mackay Clinical School, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia Tropical Health Solutions, Townsville, Queensland, Australia Queensland Centre for Chronic Disease Prevention, James Cook University, Cairns, Queensland, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Buettner
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002710:Chlorhexidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000431:Ethanol / Q000008:administration & dosage*; D058006:General Practice; D006801:Humans; D013511:Minor Surgical Procedures / Q000379:methods*; D011793:Queensland; D012997:Solvents / Q000008:administration & dosage*; D013530:Surgical Wound Infection / Q000517:prevention & control*; D014867:Water / Q000008:administration & dosage*
chemical_list: D000891:Anti-Infective Agents, Local; D012997:Solvents; D014867:Water; D000431:Ethanol; C010882:chlorhexidine gluconate; D002710:Chlorhexidine
keywords: PRIMARY CARE; SURGERY; WOUND MANAGEMENT