ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12607000537459

Ethics application status

Approved

Date submitted

18/10/2007

Date registered

19/10/2007

Date last updated

29/06/2021

Date data sharing statement initially provided

29/06/2021

Date results provided

29/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients, The HONEYPOT Study

Scientific title

A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients

Secondary ID [1]

Australasian Kidney Trials Network trial number 06.02

Universal Trial Number (UTN)

Trial acronym

HONEYPOT

Linked study record

Health condition

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

Peritoneal dialysis

Chronic renal failure

Condition category

Condition code

Renal and Urogenital

Kidney disease

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Daily exit site application of gamma-irradiated, commercially available, pooled antibacterial honeys including Leptospermum sp honey (Medihoney™ Antibacterial Wound Gel, Medihoney Pty Ltd, Australia; approximately 10 mg) following exit site cleaning and drying as per standard local practice for the duration of the study. Trial participants will be treated and followed up for 12 months from the entry of the last patient in the study. Recruitment is expected to take 2 years and median trial treatment and follow up is expected to be 18 months.

Intervention code [1]

Prevention

Comparator / control treatment

All control group patients will undertake daily exit site cleaning as per standard local practice for the duration of the study. Identified nasal carriers of Staphylococcus aureus will undergo intra-nasal application of 2% mupirocin ointment (GlaxoSmithKline, Australia) bd for 5 consecutive days each month for the duration of the trial (in accordance with the Caring for Australians with Renal Impairment (CARI) Guideline recommendations). Members of the control group who do not have nasal staphylococcal colonization will not receive mupirocin.

Control group

Active

Outcomes

Primary outcome [1]

Time to first episode of exit site infection, tunnel infection or peritonitis (whichever comes first)

Timepoint [1]

Time from study entry

Secondary outcome [1]

Costs

Timepoint [1]

Assessed throughout the study period

Secondary outcome [2]

Time to first episode of peritonitis

Timepoint [2]

Time from study entry

Secondary outcome [3]

Time to first tunnel infection

Timepoint [3]

Time from study entry

Secondary outcome [4]

Time to first exit site infection

Timepoint [4]

Time from study entry

Secondary outcome [5]

Time to infection-associated catheter removal

Timepoint [5]

Time from study entry

Secondary outcome [6]

Catheter-associated infection rates

Timepoint [6]

Assessed throughout the study period

Secondary outcome [7]

Occurrence of mupirocin-resistant microbial isolates

Timepoint [7]

Assessed throughout the study period

Secondary outcome [8]

Incidence of adverse reactions

Timepoint [8]

Assessed throughout the study period

Eligibility

Key inclusion criteria

Receiving peritoneal dialysis.
Able to give informed consent.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. Recent (within 1 month) exit site infection, peritonitis, or tunnel infection. Known hypersensitivity to, or intolerance of, honey or mupirocin. On long term antibiotics. Nasal carriage of mupirocin resistant Staphylococcus aureus.

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)

Participants will be recruited from hospital renal units providing peritoneal dialysis services in Australia and New Zealand. Patients should meet the inclusion and exclusion criteria. Eligible patients will be provided with an information and consent form. Once written consent has been obtained, study staff will randomise the patient using a web based system. Patients will be informed of the randomisation result.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be conducted utilising a web-based database to allocate the patient to a trial arm using dynamically allocated methods. Stratification will occur for study site, incident versus prevalent patient status and nasal carriage of Staph aureus. Patients will be randomised to one of two treatment groups in equal proportion.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/09/2008

Actual

17/09/2008

Date of last participant enrolment

Anticipated

Actual

17/06/2011

Date of last data collection

Anticipated

Actual

29/01/2013

Sample size

Target

370

Accrual to date

Final

371

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment postcode(s) [1]

7250

Recruitment postcode(s) [2]

5011

Recruitment postcode(s) [3]

5041

Recruitment postcode(s) [4]

5000

Recruitment postcode(s) [5]

6160

Recruitment postcode(s) [6]

6001

Recruitment postcode(s) [7]

2050

Recruitment postcode(s) [8]

4029

Recruitment postcode(s) [9]

4102

Recruitment postcode(s) [10]

4560

Recruitment postcode(s) [11]

4350

Recruitment postcode(s) [12]

4814

Recruitment postcode(s) [13]

4120

Recruitment postcode(s) [14]

2170

Recruitment postcode(s) [15]

2139

Recruitment postcode(s) [16]

2145

Recruitment postcode(s) [17]

2800

Recruitment postcode(s) [18]

2148

Recruitment postcode(s) [19]

3168

Recruitment postcode(s) [20]

3550

Recruitment postcode(s) [21]

3220

Recruitment postcode(s) [22]

3021

Recruitment postcode(s) [23]

3065

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

North & South Islands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health - Smart Health Grant

Address [1]

147-163 Charlotte Street, Brisbane Queensland 4000

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Baxter Renal Discoveries Extramural Grant

Address [2]

One Baxter Parkway, Deerfield, IL 60015-4625

Country [2]

United States of America

Primary sponsor type

University

Name

Australasian Kidney Trials Network

Address

University of Queensland at Ground Floor, Building 33, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research Ethics Committee

Ethics committee address [1]

University of Queensland, St Lucia, Brisbane 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2007

Approval date [1]

04/07/2007

Ethics approval number [1]

2007000591

Summary

Brief summary

The largest problem faced by peritoneal dialysis patients is infection of their dialysis catheter, which can occur at the point of entry of the catheter into the belly (exit site infection), along the catheter tunnel (tunnel infection) or inside the belly (peritonitis). Such infections are the commonest cause of death or failure of treatment in peritoneal dialysis patients at Princess Alexandra Hospital. Recent studies have suggested that honey may be a promising agent for preventing catheter-associated infections. Honey has natural antibacterial and antifungal actions and has been shown to be very effective in preventing infection when applied to a variety of wounds, including burns, ulcers and surgical wounds. A previous controlled trial by our group in haemodialysis patients showed that honey was as effective as, and less likely to select resistant germs than, standard antibiotic ointment (mupirocin). The purpose of the present proposed study is to determine if exit site application of standardised antibacterial honey (Medihoney Wound Gel) is more effective at preventing infection of peritoneal dialysis catheters than the standard antibiotic ointment, mupirocin, which is currently recommended by national guidelines.

Trial website

www.aktn.org.au

Trial related presentations / publications

Johnson DW, Clark C, Isbel NM, Hawley CM, Beller E, Cass A, de Zoysa J,McTaggart S, Playford G, Rosser B, Thompson C, Snelling P; the HONEYPOT Study Group. THE HONEYPOT STUDY PROTOCOL: A RANDOMIZED CONTROLLED TRIAL OF EXIT-SITE APPLICATION OF MEDIHONEY ANTIBACTERIAL WOUND GEL FOR THE PREVENTION OF CATHETER-ASSOCIATED INFECTIONS IN PERITONEAL DIALYSIS PATIENTS. Perit Dial Int. 2009 May; 29(3):303-309.2007 Impact factor: 1.995

Badve, Sunil; Smith, Alicia; Hawley, Carmel; Johnson, David W. Letter: ADHERENCE TO GUIDELINE RECOMMENDATIONS FOR INFECTION PROPHYLAXIS IN PERITONEAL DIALYSIS PATIENTS. NDT Plus. 2009 December; 2(6): 508.

Pascoe EM, Lo, S, Scaria, A, Badve SV, Beller EM, Cass A, Hawley CM, Johnson DW. The HONEYPOT RANDOMIZED CONTROLLED TRIAL STATISTICAL ANALYSIS PLAN. Perit Dial Inter. July-August 2013 33(4): 426-435 

David W Johnson, Sunil V Badve, Elaine M Pascoe, Elaine Beller, Alan Cass, Carolyn Clark, Janak de Zoysa, Nicole M Isbel, Steven McTaggart, Alicia T Morrish, E Geoff rey Playford, Anish Scaria, Paul Snelling, Liza A Vergara, Carmel M Hawley, for the HONEYPOT Study Collaborative Group. Antibacterial honey for the prevention of peritoneal dialysis-
related infections (HONEYPOT): a randomised trial. The Lancet Infectious Diseases 2014; 14(1): 23-30

Lei Zhang, Sunil V. Badve, Elaine M. Pascoe, Elaine Beller, Alan Cass, Carolyn Clark, Janak de Zoysa, Nicole M Isbel, Steven McTaggart, Alicia T. Morrish, Geoffrey Playford, Anish Scaria, Paul Snelling, Liza A. Vergara, Carmel M. Hawley, and David W. Johnson for the HONEYPOT Study Collaborative Group. The effect of exit site antibacterial honey versus nasal mupirocin prophylaxis on the microbiology and outcomes of peritoneal dialysis-associated peritonitis and exit site infections: a sub-study of the HONEYPOT trial. Accepted by PDI (PDI-2014-00206.R1), waiting for reference

Public notes

Contacts

Principal investigator

Name

Prof David Johnson

Address

Australasian Kidney Trials Network (UQ) Ground Floor, Bldg 33 Princess Alexandra Hospital 199 Ipswich Road, WOOLLOONGABBA QLD 4102

Country

Australia

Phone

+61 7 3176 5463

Fax

[email protected]

Contact person for public queries

Name

Alicia Morrish

Address

Australasian Kidney Trials Network (UQ)
Ground Floor, Bldg 33
Princess Alexandra Hospital
199 Ipswich Road,
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

+61 7 3443 5463

Fax

07 3176 5663

[email protected]

Contact person for scientific queries

Name

David Johnson

Address

Department of Nephrology, ARTS Building, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Brisbane 4102

Country

Australia

Phone

61 7 3240 5080

Fax

61 7 3240 5480

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12353	Statistical analysis plan		https://aktn.org.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of exit-site antibacterial honey versus nasal mupirocin prophylaxis on the microbiology and outcomes of peritoneal dialysis-associated peritonitis and exit-site infections: A sub-study of the Honeypot trial.	2015	https://dx.doi.org/10.3747/pdi.2014.00206

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically