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Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis Study

Cluster Randomised Controlled Trial comparing Surgical Skin Preparation with Alcoholic Chlorhexidine versus Alcoholic Iodine for the Prevention of Superficial Wound Complications in Prosthetic Hip and Knee Replacement Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000177651
Acronym
ACAISA
Enrollment
780
Registered
2014-02-13
Start date
2014-08-11
Completion date
2016-01-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis (ACAISA) Study is a cluster randomised controlled trial comparing alcoholic chlorhexidine to alcoholic iodine skin antisepsis at the time of surgery for prevention of superficial wound complications in patients undergoing elective prosthetic hip and knee replacement surgery. Skin antisepsis is a simple and effective strategy to remove soil and microorganisms from the patient’s skin prior to surgical incision. The three main agents commonly used for skin antisepsis are chlorhexidine, iodophors (such as iodine) or alcohol. Despite their use for over a century, no studies have adequately assessed the comparative effects of these agents on wound complication risk, particular in patients undergoing orthopaedic surgery. Joint replacement surgery is a national healthcare priority and represents high volume, high cost surgery. In 2011, 90 000 Australian patients underwent prosthetic joint surgery and this rate will double by 2020. The conservative estimate of direct medical costs for prosthetic joint surgery in Australia is $2 billion annually. Superficial wound complications are a major cause of morbidity for patients following prosthetic joint replacement surgery and are associated with increased risk of deep prosthetic joint infection. In addition, treatment of superficial wound complications are estimated to add a further $34 million annually to the direct cost of prosthetic joint surgery. Prevention of superficial wound complications will substantially decrease morbidity and mortality, improve patient outcomes and reduce the economic burden to the healthcare system. The ACAISA study represents an international first. In addition, this study is a unique collaboration between orthopaedic surgeons, infectious diseases clinicians and infection control practitioners in both the public and private healthcare sector.

Interventions

The aim of this cluster randomised controlled trial is to compare the incidence of superficial wound complications in all patients undergoing elective prosthetic hip or knee replacement surgery receiving surgical skin preparation with either: 0.5% chlorhexidine gluconate in 70% alcohol or 1% iodine in 70% alcohol.

Sponsors

Professor Peter Choong
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants undergoing hip or knee replacement surgery

Exclusion criteria

Patients with a documented allergy to chlorhexidine, alcohol, or iodophors Patients with a primary language other than English for which certified translation services for that specific language are not available Patients undergoing arthroplasty surgery for traumatic fractured neck of femur Patients undergoing insertion of an tumour endoprosthesis for bone and soft tissue tumours

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026