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Trial registered on ANZCTR


Registration number
ACTRN12614000177651
Ethics application status
Approved
Date submitted
10/02/2014
Date registered
13/02/2014
Date last updated
19/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis Study
Scientific title
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
Secondary ID [1] 284064 0
Nil
Universal Trial Number (UTN)
U1111-1153-2057
Trial acronym
ACAISA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prosthetic joint replacement surgery 291120 0
Superficial wound complications 291121 0
Condition category
Condition code
Surgery 291462 291462 0 0
Other surgery
Infection 291463 291463 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288759 0
Prevention
Comparator / control treatment
Both surgical skin preparation agents are currently used as part of standard care in patients undergoing surgery.
Control group
Active

Outcomes
Primary outcome [1] 291444 0
Superficial surgical wound complications, specificially superficial incisional surgical site infections (as defined by the Centers for Disease Control / National Healthcare Safety Network) and prolonged wound ooze (wound ooze requiring intervention, such as superficial surgical debridement). These will be assessed clinically.
Timepoint [1] 291444 0
30 days
Secondary outcome [1] 306778 0
The incidence of superficial surgical wound complications according to the joint replaced (knee or hip). Superficial surgical wound complications include either superficial incisional surgical site infections (as defined by the CDC / NHSN) and prolonged wound ooze (wound ooze requiring intervention, such as superficial surgical debridement). These will be assessed clinically.
Timepoint [1] 306778 0
30 days
Secondary outcome [2] 306779 0
Assessment of the causative microorganisms of surgical site infections. The diagnosis of surgical site infections is clinical and is according to the CDC/NHSN definition).
Timepoint [2] 306779 0
30 days
Secondary outcome [3] 306780 0
Undesirable adverse consequences from surgical skin preparation (SSP) including toxicity and allergies. This will be assessed clinically.
Timepoint [3] 306780 0
30 days
Secondary outcome [4] 306781 0
Economic analysis including cost-effectiveness of surgical skin preparation. We will apply health economic modelling to estimate the potential cost-effectiveness of 0.5% chlorhexidine in 70% alcohol compared with 1% iodine in 70% alcohol. Decision analysis will be used to compare the downstream consequences of SSP. The incorporation of Markov and life-tabling techniques will allow for the modelling of outcomes beyond one year. The main output of interest in health economic modelling is incremental cost-effectiveness ratios in terms of net costs per unit of health gain. Net costs will comprise the costs of the SSP agents minus costs saved from the reduction in downstream health services utilization. Health gains can be measured in a variety of ways. In our study, other than clinical outcomes, we will be also estimating years of life gained and quality-adjusted life years (QALYs) gained. Both are enabled by the collection of time-to-outcome data and the latter also by collection of quality of life data. All health economic analyses will be undertaken in accordance with recommended approaches, such as 5% discounting of estimated future costs and health gains. To account for any uncertainty in the data inputs for health economic modelling, sensitivity and uncertainty analyses will be undertaken via Monte Carlo simulation.
Timepoint [4] 306781 0
30 days

Eligibility
Key inclusion criteria
Participants undergoing hip or knee replacement surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study population will be drawn from patients on the waiting list for elective hip and knee replacement surgery at St Vincent's Hospital (Melbourne). Once a participant is placed on the waiting list, they will be sent the Patient Information Statement for Opt-Out Consent, which will detail the problem of SWC and the nature of the study. In addition the Patient Information Statement for Opt-Out Consent will explain the process to ‘opt-out’ of the study. Two weeks after the Patient Information Statement for Opt-Out Consent is sent to the participant, the Project Research Officer will review the medical record; any potential participant with a documented allergy to either study agent, will be excluded from the study.
In the opt-out approach, willingness to participate is presumed unless the participant communicates a choice not to participate in the research. Eligible participants undergoing hip or knee replacement surgery on a given day will be randomly assigned in a ratio of 1:1 to have skin preparation either with 0.5% chlorhexidine gluconate in 70% alcohol or 1% iodine in 70% alcohol.
the research team involved in the assessment or treatment of patients will have no role in the assignment process. The patients will be blinded to treatment allocation. We recognise that blinding of the operating surgeons to the assigned preventative strategy is not feasible , however the operating surgeons will be blinded to the allocation until the day of surgery. In addition, the Project Research Officer will be blinded and data will be analysed on an intention-to-treat basis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by a computer-generated random assignment sequence prepared in advance by a statistician. Opaque, numbered, tamperproof envelopes containing assignment will be prepared in advance.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomised controllled trial based on the day of surgery
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis is an intention to treat analysis including all participants who underwent randomisation. Factors associated with SWC will be examined by chi-squared tests or Fisher’s exact tests for categorical variables or Student t-tests (parametric) or Mann-Whitney test (non-parametric) for continuous variables. Time-to-outcome data will also be collected and the independent contribution of relevant factors associated with SWC will be assessed using multivariable Cox proportional hazard regression. All reported p-values will be two-tailed and for each analysis p<0.05 will be considered statistically significant.

The sample size calculations were based on pilot data; the proportion of patients with superficial wound complications was 27% in the 0.5% chlorhexidine/70% alcohol group versus 8% of patients in the 1% iodine/70% alcohol group. On multivariate analysis there was an 80% reduction in the risk of superficial wound complications in the group receiving 1% iodine in 70% alcohol SSP (Odds Ratio 0.20, 95% Confidence Intervals[CI]; 0.06,0.67). The sample size estimation for this study is based on the worst case scenario (based on the upper limit of the 95% CI of the pilot study) and includes the following parameters: (i) alpha value = 0.05, 2-sided; (ii) power = 80%; (iii) expected rates of the primary outcome (defined above) at 30 days post prosthetic hip or knee replacement surgery of 27% for 0.5% chlorhexidine in 70% alcohol and 18% for 1% iodine in 70% alcohol. The sample size required in each of the 2 (equally-sized) groups is 359 patients. To allow for an estimated lost to follow-up rate of 5%, we will recruit 750 patients in total. At St Vincent's Hospital (Melbourne), over 700 prosthetic joint replacements are performed each year therefore recruitment will be completed over the first 2 years of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
11/08/2014
Date of last participant enrolment
Anticipated
Actual
22/01/2016
Date of last data collection
Anticipated
22/06/2017
Actual
22/01/2017
Sample size
Target
750
Accrual to date
Final
780
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4138 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Funding & Sponsors
Funding source category [1] 288694 0
Government body
Name [1] 288694 0
NHMRC
Country [1] 288694 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Choong
Address
Director
Department of Surgery, St Vincent's Hospital (Melbourne)
29 Regent Street
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 287399 0
None
Name [1] 287399 0
Address [1] 287399 0
Country [1] 287399 0
Other collaborator category [1] 277819 0
Individual
Name [1] 277819 0
Dr Trisha Peel
Address [1] 277819 0
Department of Surgery, St Vincent's Hospital (Melbourne)
29 Regent Street
Fitzroy
VIC 3065
Country [1] 277819 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290536 0
St Vincent's Hospital (Melbourne) HREC-A
Ethics committee address [1] 290536 0
Ethics committee country [1] 290536 0
Australia
Date submitted for ethics approval [1] 290536 0
19/02/2014
Approval date [1] 290536 0
11/03/2014
Ethics approval number [1] 290536 0
HREC-A 016/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46142 0
Prof Peter Choong
Address 46142 0
Director
Department of Surgery, St Vincent's Hospital (Melbourne)
29 Regent Street
Fitzroy, VIC 3065
Country 46142 0
Australia
Phone 46142 0
+61 3 9288 2365
Fax 46142 0
+61 3 9416 3610
Email 46142 0
pchoong@unimelb.edu.au
Contact person for public queries
Name 46143 0
Trisha Peel
Address 46143 0
Department of Infectious Diseases, Monash University, 85 Commercial Road, Melbourne, VIC 3004
Country 46143 0
Australia
Phone 46143 0
+61 3 9076 2000
Fax 46143 0
+61 3 90762431
Email 46143 0
trisha.peel@monash.edu
Contact person for scientific queries
Name 46144 0
Trisha Peel
Address 46144 0
Department of Infectious Diseases, Monash University, 85 Commercial Road, Melbourne, VIC 3004
Country 46144 0
Australia
Phone 46144 0
+61 3 9076 2000
Fax 46144 0
+62 3 90762431
Email 46144 0
trisha.peel@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo KEY POINTS Question Does surgical site skin prep... [More Details]
Study results articleYes https://www.ncbi.nlm.nih.gov/pubmed/?term=Chlorhex... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAlcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis (ACAISA): Protocol for cluster randomised controlled trial of surgical skin preparation for the prevention of superficial wound complications in prosthetic hip and knee replacement surgery.2014https://dx.doi.org/10.1136/bmjopen-2014-005424
N.B. These documents automatically identified may not have been verified by the study sponsor.