Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000698875
Ethics application status
Approved
Date submitted
26/06/2012
Date registered
29/06/2012
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of sterile versus non-sterile clean boxed gloves on surgical site infection during minor skin excisions in general practice: A prospective randomised control trial
Scientific title
Effect of sterile versus non-sterile clean boxed gloves on surgical site infection during minor skin excisions in general practice: A prospective randomised control trial
Secondary ID [1] 280739 0
nil
Universal Trial Number (UTN)
U1111-1132-0825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presence of surgical site infection post minor skin excision in general practice setting 286778 0
Condition category
Condition code
Infection 287088 287088 0 0
Studies of infection and infectious agents
Surgery 287116 287116 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of non-sterile clean boxed gloves during minor skin excisions in general practice (gloves used will be latex or nitrile) unless patients or doctor is allergic to latex) this will be carried out at the general practice for a duration of 9 months
Intervention code [1] 285155 0
Treatment: Devices
Intervention code [2] 285180 0
Treatment: Surgery
Intervention code [3] 285181 0
Prevention
Comparator / control treatment
Sterile gloves for minor skin excisions in general practice (latex or non-latex type) for a duration of 9 months
Control group
Active

Outcomes
Primary outcome [1] 287410 0
Presence or absence of surgical site infection. This will be determined using the CDC definition of surgical site infection: is an infection which occurs within 30 days after the excision AND infection involves only skin or subcutaneous tissue of the incision, and at least ONE of the following: a purulent drainage with or without laboratory confirmation from the superficial incision, at least one of the signs or symptoms of infection: pain or tenderness, localised swelling, redness or heat OR if diagnosis of infection is made by the general practitioner. A stitch abscess is not considered as a superficial site infection.

Chi-squared test will then be used in order to determine how effective sterile or non-sterile gloves are in regards to infection, baseline comparison would be made between both the sterile and non-sterile groups in order to ensure that all variables are equally distributed in both arms of the trial.
Timepoint [1] 287410 0
At time of removal of sutures, if excision on back- 10-14 days; if on other sites 5-7 days. Patients can present up to 30 days to be considered as a post-operative surgical site infection.
Secondary outcome [1] 298089 0
nil
Timepoint [1] 298089 0
nil

Eligibility
Key inclusion criteria
All patients presenting to the participating general practice who require removal of minor skin excision anywhere on their body are eligible to participate
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patients who are already taking oral antibiotics
- those who require oral or topical antibiotics post-opratively
- immunocompromsed
- repair of lacerations
- having a flap procedure
- those with latex allergies
- excision not requring sutures such as shave biopsies
- lesions on body where adrenaline is contraindicated

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)
Computer generated random numbers will be used in order to allocate patients to either interventional or control group. These will be done by the primary investigator and placed in opaque envelopes to ensure that no tampering is associated with it. Patients will be randomised after signed consent has been attained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using randomisation table created by a computer software (computer generated random numbers), then every even number - non-sterile and odd number sterile
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2012
Actual
30/06/2012
Date of last participant enrolment
Anticipated
Actual
28/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285516 0
University
Name [1] 285516 0
James Cook University - contribution for Honours students
Country [1] 285516 0
Australia
Primary sponsor type
Individual
Name
Shampavi Sriharan
Address
JCU School of Medicine and Dentistry, Mackay Base Hospital
475 Bridge Road West Mackay QLD 4740
Country
Australia
Secondary sponsor category [1] 284355 0
Individual
Name [1] 284355 0
Dr Clare Heal
Address [1] 284355 0
JCU School of Medicine and Dentistry, Mackay Base Hospital
475 Bridge Road West Mackay QLD 4740
Country [1] 284355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287529 0
James Cook University Human research Ethics committee
Ethics committee address [1] 287529 0
James Cook University
Research Ethics and Grants
1 James Cook Drive, Townsville QLD 4811
Ethics committee country [1] 287529 0
Australia
Date submitted for ethics approval [1] 287529 0
Approval date [1] 287529 0
17/05/2012
Ethics approval number [1] 287529 0
H4572

Summary
Brief summary
This project aims to determine whether the use of non-sterile clean boxed gloves in comparison to the existing guidelines of using sterile gloves in minor skin excisions has an effect on surgical site infection (SSI).

Hypothesis: The use of non-sterile clean boxed gloves in minor skin excisions in general practice will not have an effect in increasing surgical site infections (SSI) compared to use of sterile gloves.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34360 0
Dr Shampavi Sriharan
Address 34360 0
JCU School of Medicine and Dentistry
K Block
Mackay Base Hospital
Mackay 4740
Qld
Country 34360 0
Australia
Phone 34360 0
+61437495002
Fax 34360 0
Email 34360 0
[email protected]
Contact person for public queries
Name 17607 0
Dr Shampavi Sriharan
Address 17607 0
James Cook University School of Medicine and Dentistry, Mackay Base Hospital
475 Bridge Road, West Mackay QLD 4740
Country 17607 0
Australia
Phone 17607 0
61 (0)437495002
Fax 17607 0
Email 17607 0
[email protected]
Contact person for scientific queries
Name 8535 0
Dr Shampavi Sriharan
Address 8535 0
James Cook University School of Medicine and Dentistry, Mackay Base Hospital
475 Bridge Road, West Mackay QLD 4740
Country 8535 0
Australia
Phone 8535 0
61 (0)437495002
Fax 8535 0
nil
Email 8535 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.