ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

EVALUATE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bacterial Load - Skin

Blood Donation

Condition category

Condition code

Skin

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]

Treatment: Devices

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

within 5 minutes from removal of Coolsense(R) Device

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Red Cross Blood Service

Address [1]

National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Red Cross Blood Service Ethics Committee

Ethics committee address [1]

C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/09/2016

Approval date [1]

30/09/2016

Ethics approval number [1]

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

Dr Tanya Davison

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9863 1600

Fax

BS_ClinicalTrials@redcrossblood.org.au

Contact person for public queries

Name

Elizabeth Knight

Address

Australian Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Country

Australia

Phone

+61 2 8234 2386

Fax

BS_ClinicalTrials@redcrossblood.org.au

Contact person for scientific queries

Name

Carley Gemelli

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9863 1600

Fax

BS_ClinicalTrials@redcrossblood.org.au

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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Documents added automatically

No additional documents have been identified.

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