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Trial registered on ANZCTR


Registration number
ACTRN12617000194369
Ethics application status
Approved
Date submitted
24/01/2017
Date registered
6/02/2017
Date last updated
9/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to Assess Bacterial load after a pain numbing device is applied to a blood donor's arm after routine disinfection
Scientific title
A prospective study to Assess Bacterial load after a non-invasive pain numbing device is placed on a blood donor's arm after routine disinfection
Secondary ID [1] 290991 0
Nil
Universal Trial Number (UTN)
Trial acronym
EVALUATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Load - Skin 301751 0
Blood Donation 301767 0
Condition category
Condition code
Skin 301455 301455 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will assess the impact a non-invasive pain numbing device - Coolsense(R) has on the skin surface bacterial load collected from a blood donor's cubital fossa after routine disinfection of the area with BD Persist Plus on their non phlebotomy arm.

Coolsense (R) is a topical anaesthetic device that numbs the skin prior to injection. The device consists of an applicator, which has an in-built temperature gauge, as well as an antiseptic component to clean the applicator. The device is applied to the skin for 10 seconds to numb the phlebotomy site

BD Persist Plus contains 1% Chlorhexidine Gluconate with 75% Ethanol that is applied with a single use applicator.

Each donor will have their non phlebotomy cubital fossa disinfected with BD Persist Plus which is as per The Blood Services standard practice. After the Persist Plus has dried a skin swab will be taken before and after the application of the Coolsense(R) Device which for the purposes of this study only has been kept at room temperature.

The tip of the device will have a small quantity, approximately 5 cent piece size of 70% Alcohol gel applied prior to contact with the skin. The gel will be allowed to dry prior to the 2nd arm swab being taken.
Intervention code [1] 296955 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300852 0
Proportion of participants for who the bacterial colony count post application of the Coolsense(R) device is less than 5 colony units.

Bacterial colony count will be measured by taking a skin swab pre and post the application of the Coolsense(R) device. Swabs are then inoculated and contents transferred to a Petrifilm (TM) plate where it is incubated at 30 degrees for 72 hours to allow for any bacterial growth. Samples are then removed from the incubator and colonies are counted within the circular growth area (approx 20cm squared)
Timepoint [1] 300852 0
within 5 minutes from removal of Coolsense(R) Device
Secondary outcome [1] 331034 0
Proportion of participants for whom the bacterial colony count post application of the Coolsense(R) device is no greater than the colony count prior to application of the device.

Bacterial colony count will be measured by taking a skin swab pre and post the application of the Coolsense(R) device. Swabs are then inoculated and contents transferred to a Petrifilm (TM) plate where it is incubated at 30 degrees for 72 hours to allow for any bacterial growth. Samples are then removed from the incubator and colonies are counted within the circular growth area (approx 20cm squared)
Timepoint [1] 331034 0
within 5 minutes from removal of Coolsense(R) Device

Eligibility
Key inclusion criteria
1. Adults greater than or equal to 18 years and less than 80 years
2. Eligible for blood donation as per the current ‘Guidelines for the Selection of Blood Donors’ (GSBD)
3. At least 2 previous successful donations (Plasma, Platelet or Whole Blood)
4. Able and Willing to provide written informed consen
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Does not meet current ‘Guidelines for the Selection of Blood Donors’ (GSBD)
2. Known sensitivity to Isopropyl Alcohol and or other topical disinfectants

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome will be analysed by summarising and tabulating the number of samples collected where colony units are greater than or less than 5 units. The secondary outcome will use an appropriate means test to determine the difference between colony units pre and post intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/11/2016
Date of last participant enrolment
Anticipated
Actual
12/12/2016
Date of last data collection
Anticipated
Actual
12/12/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295411 0
Charities/Societies/Foundations
Name [1] 295411 0
Australian Red Cross Blood Service
Country [1] 295411 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 294232 0
None
Name [1] 294232 0
Address [1] 294232 0
Country [1] 294232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296744 0
Australian Red Cross Blood Service Ethics Committee
Ethics committee address [1] 296744 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 296744 0
Australia
Date submitted for ethics approval [1] 296744 0
06/09/2016
Approval date [1] 296744 0
30/09/2016
Ethics approval number [1] 296744 0
2016#20

Summary
Brief summary
A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year.

We propose that a pain numbing device called “CoolSense(R)" could be effectively used by the Blood Service to reduce pain and anxiety, and enhance donor satisfaction and retention. CoolSense(R) is a hand-held non- invasive skin numbing applicator that is used to anaesthetise the skin before a painful procedure, without the use of chemicals. With an operating temperature of minus two to minus six degrees Celsius, CoolSense(R) is more effective than ice in numbing pain. In order to use CoolSense(R) in phlebotomy, the applicator must be applied to the skin after disinfection as the site would not remain desensitized for a sufficient period if applied prior to disinfection. Given that this post-disinfection application contravenes current Blood Service protocols, the objective of the bacterial load study is to assess whether the phlebotomy site remains free from microbiological contaminates after application of CoolSense(R)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71938 0
Dr Tanya Davison
Address 71938 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia
Country 71938 0
Australia
Phone 71938 0
+61 3 9863 1600
Fax 71938 0
Email 71938 0
[email protected]
Contact person for public queries
Name 71939 0
Elizabeth Knight
Address 71939 0
Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 71939 0
Australia
Phone 71939 0
+61 2 8234 2386
Fax 71939 0
Email 71939 0
[email protected]
Contact person for scientific queries
Name 71940 0
Carley Gemelli
Address 71940 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia
Country 71940 0
Australia
Phone 71940 0
+61 3 9863 1600
Fax 71940 0
Email 71940 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

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