Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001051831
Ethics application status
Approved
Date submitted
30/09/2012
Date registered
3/10/2012
Date last updated
14/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Intranasal white petrolatum versus chlorhexidine to reduce postoperative infections in dermatologic surgery
Scientific title
In patients scheduled for dermatologic surgery, is intranasal white petrolatum or chlorhexidine more effective than normal saline in reducing postoperative infections?
Secondary ID [1] 281326 0
Nil
Universal Trial Number (UTN)
U1111-1135-3062
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence of postoperative wound infections 287542 0
Prevalance of staphylococcus aureus carriage 287543 0
Skin Cancer 287561 0
Condition category
Condition code
Surgery 287867 287867 0 0
Other surgery
Cancer 287868 287868 0 0
Non melanoma skin cancer
Infection 287869 287869 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Referrals to the Skin Centre for excision of skin cancers will be selected for possible inclusion by one of five participating Consultant Dermatologists. Eligible and consenting patients will at the time of consultation for surgery, fill in a short questionnaire for demographic data and have a nasal swab to assess staphylococcus aureus carriage. The patients will be randomised to either intranasal white petrolatum, 2% chlorhexidine or normal saline to the anterior nares. Five days prior to elective surgery, all patients will apply one of three treatments (depending on randomisation) to the anterior nares twice daily. In the chlorhexidine arm and the normal saline arm, this will be in the manner of a soaked cotton bud whereas in the white petrolatum arm, this will be in the manner of a cotton bud application. All patients will have their wound assessed at the time of suture removal (expected range: 5 – 14 days depending on type of surgery) or if any clinical signs of wound infection occur outside this time frame (up to one month post-surgery). All infected wounds will be swabbed. The incidence of wound infection will be collected and a comparison will be made to the incidence of wound infection in patients being treated with intranasal white petrolatum, 2% chlorhexidine and individuals using intranasal normal saline.
Intervention code [1] 285789 0
Treatment: Other
Intervention code [2] 285799 0
Prevention
Comparator / control treatment
Placebo - Normal saline in anterior nares twice daily for five days prior to elective surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 288089 0
To assess the efficacy of intranasal application of white petrolatum or chlorhexidine for reducing wound infections. The incidence of wound infections in the group using white petrolatum or chlorhexidine in the anterior nares (nostrils) will be compared to the incidence of wound infections in the group using normal saline.
Timepoint [1] 288089 0
12 months after randomisation
Secondary outcome [1] 299402 0
To determine the prevalance of nasal carriage of staphylococcus aureus. The number of nasal swabs being positive (positive culture for growth) for staphylococcus aureus amongst the entire study population will be reported.
Timepoint [1] 299402 0
12 months after randomisation
Secondary outcome [2] 299403 0
To determine which patients would benefit most from this approach if proven to be effective. A subgroup analysis would be performed to determine if there are any patient related factors (eg. Age, recent hospitalisation etc) which would place the patient at high risk for intranasal staphylococcus aureus carriage or high risk of post-operative wound infections.
Timepoint [2] 299403 0
12 months after randomisation
Secondary outcome [3] 299404 0
To prove the cost-effectiveness of this method to reduce wound infections. The cost of intranasal white petrolatum and 2% chlorhexidine would be compared against the cost of managing post-operative wound infection.
Timepoint [3] 299404 0
12 months after randomisation

Eligibility
Key inclusion criteria
Patients scheduled for elective dermatologic surgery for removal of skin cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current infection
Current antibiotic therapy
Antibiotic use in the last month
Failure to have intranasal swab to assess carriage of S. aureus prior to surgery

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)
Central randomisation by computer. Each enrolled patient would be allocated a number and central randomisation by a computer program will be utilised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using block randomisation where patients will be allocated to treatment of intranasal white petrolatum or intranasal normal saline per surgeon per time.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4578 0
New Zealand
State/province [1] 4578 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 286088 0
Other Collaborative groups
Name [1] 286088 0
Skin Cancer Institute
Country [1] 286088 0
New Zealand
Primary sponsor type
Individual
Name
Eugene Tan
Address
Skin Cancer Institute
171 Cameron Road
Tauranga 3110
Country
New Zealand
Secondary sponsor category [1] 284902 0
Individual
Name [1] 284902 0
Paul Salmon
Address [1] 284902 0
Skin Cancer Institute
171 Cameron Road
Tauranga 3110
Country [1] 284902 0
New Zealand
Other collaborator category [1] 277102 0
Individual
Name [1] 277102 0
Neil Mortimer
Address [1] 277102 0
Skin Cancer Institute
171 Cameron Road
Tauranga 3110
Country [1] 277102 0
New Zealand
Other collaborator category [2] 277112 0
Hospital
Name [2] 277112 0
Associate Professor Marius Rademaker
Address [2] 277112 0
Waikato Hospital
Pembroke Street
Hamilton
Country [2] 277112 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288142 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288142 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 288142 0
New Zealand
Date submitted for ethics approval [1] 288142 0
30/10/2012
Approval date [1] 288142 0
16/01/2013
Ethics approval number [1] 288142 0
12/NTA/79

Summary
Brief summary
New Zealand has the highest rate of skin cancers in the world which leads to a large number of skin excisions. About 30-40% of the population carry a bacterium known as Staphylococcus aureus. Carriage of this bacterium has been shown to increase the risk of surgical wound infections by up to eight times. Earlier studies have assessed the effectiveness of a topical antibiotic, mupirocin to eradicate carriage of Staphylococcus aureus. Unfortunately, this method has been complicated by bacterial resistance and allergic skin reactions. In this study, we want to see whether applying white petrolatum (Vaseline) or Chlorhexidine is effective for eradicating nasal carriage of staphylococcus aureus and reducing wound infections in dermatologic surgery. If proven to be effective, this simple method may be a safe and economic method to reduce the incidence of wound infections in dermatologic surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34778 0
Dr Eugene Tan
Address 34778 0
Skin Cancer Institute
171 Cameron Road
Tauranga 3110
Country 34778 0
New Zealand
Phone 34778 0
+64-7-5785788
Fax 34778 0
Email 34778 0
[email protected]
Contact person for public queries
Name 18025 0
Dr Dr. Eugene Tan
Address 18025 0
171 Cameron Road
Tauranga 3110
Country 18025 0
New Zealand
Phone 18025 0
+64-7-5785788
Fax 18025 0
Email 18025 0
[email protected]
Contact person for scientific queries
Name 8953 0
Dr Dr. Eugene Tan
Address 8953 0
171 Cameron Road
Tauranga 3110
Country 8953 0
New Zealand
Phone 8953 0
+64-7-5785788
Fax 8953 0
Email 8953 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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