Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001080213
Ethics application status
Approved
Date submitted
15/12/2009
Date registered
16/12/2009
Date last updated
17/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of Eutectic Mixture of Lidocaine and Prilocaine (EMLA) cream as a primary dressing for painful chronic leg ulcers: A pilot study.
Scientific title
A randomised controlled trial of Eutectic Mixture of Lidocaine and Prilocaine (EMLA) cream as a primary dressing for the reduction in wound related pain associated with chronic leg ulcers: A pilot study.
Secondary ID [1] 1203 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduction of pain in lower leg ulcers. 256412 0
Condition category
Condition code
Anaesthesiology 256581 256581 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be randomized to receive EMLA 5% to their painful chronic lower leg ulcers daily as a primary dressing daily for a total of 4 weeks. The dose is 1gm per 10 sq cms. This topical cream will be applied to the wound bed by the participating community clinic nurses
Intervention code [1] 255699 0
Treatment: Drugs
Comparator / control treatment
Control group will receive receive dressings deemed appropriate by the nurse at each required clinic visit. Visits to the clinic by the control group will be determined by the clinical presentation of the wound. Visits could be daily up to weekly. The dressing choices will reflect usual care options and will include primary dressings such as: alginate, hydrofibre, hydrogel, enzyme alginogel, povidone iodine mesh, cadexamer iodine, silver impregnated dressings.
Control group
Active

Outcomes
Primary outcome [1] 257471 0
Wound-related pain (WRP) intensity and quality.
WRP intensity was measured using the Numerical Rating Scale.
WRP quality was measured from data collected using the Wound-related pain at dressing assessment tool - Question 5 on the tool.
Timepoint [1] 257471 0
Measured at baseline and at every dressing change for 12 weeks.
Secondary outcome [1] 262653 0
Health-related quality of life using the validated Cardiff Wound Impact Schedule.
Timepoint [1] 262653 0
Measured at baseline and weeks 4 and 12.
Secondary outcome [2] 262654 0
Another secondary clinical outcome was wound healing. Wound surface areas were measured.
Wound measurement was conducted by a specialist nurse in wound care not blinded to subjects group allocation.

To detect changes in wound appearance the validated Leg Ulcer Measurement Tool was used.
Timepoint [2] 262654 0
Measured at baseline and weeks 4 and 12.

Eligibility
Key inclusion criteria
Patient has one or more chronic lower leg ulcer(s) of at least 6 weeks duration and up to 100cm2 in size in total.

Patients with low to moderate wound exudate.
Numerical Rating Scale pain score = 4 at assessment and/or within the previous week.

Patients currently requiring oral analgesics due to previously reported wound-related pain.
Patients have the capacity to consent to participation.
Patients have the capacity to attend the Community Nursing Procedure clinics.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients scheduled for leg amputation.

History of peripheral sensory neuropathy of the feet.

Patients that have had or require the use of EMLA cream for debridement of the wound bed within the previous 4 weeks.

Patients with suspected wound malignancy or pyoderma gangrenosum, confirmed by biopsy.

Patients with diagnosed localized or spreading clinical wound infection.

End stage palliative care patients.

Allergy to EMLA cream and/or history of local anesthetic drug sensitivity

A history of congenital or idiopathic methemoglobinemia

Patients on Class III anti-arrhythmic drugs.

Severe hepatic disease.

Pregnant and/or lactating women.

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)
PASS 2008 Power Analysis and Sample Size software (NCSS, Kaysville, Utah) was used to generate the allocation sequence by a researcher not involved with screening patients; the investigator was blinded to the allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data were entered and checked for missing and invalid values in Microsoft Excel® then imported into Statistical Analysis for Social Scientists (SPSS Version 22, Chicago, USA) for analysis. A random sample (10%) of the data was verified against the original case report form. Quantitative data were analysed using descriptive statistics. Qualitative data from field notes were analysed using descriptive content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2010
Actual
16/09/2010
Date of last participant enrolment
Anticipated
Actual
20/03/2013
Date of last data collection
Anticipated
Actual
12/06/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256181 0
Government body
Name [1] 256181 0
NSW Department of Health Nursing & Midwifery Office
Country [1] 256181 0
Australia
Funding source category [2] 299230 0
Government body
Name [2] 299230 0
Central Coast Local Health District Central Coast Health Research Advisory Committee
Country [2] 299230 0
Australia
Funding source category [3] 299231 0
Charities/Societies/Foundations
Name [3] 299231 0
Australian Wound Management Association Research Foundation
Country [3] 299231 0
Australia
Primary sponsor type
Hospital
Name
Central Coast Local Health District
Address
Central Coast Community Nursing Service
Wyong Community Health Centre
38A Pacific Hwy
Wyong NSW 2259
Country
Australia
Secondary sponsor category [1] 251520 0
Hospital
Name [1] 251520 0
Central Coast Local Health District Division of Aged, Subacute & Complex Care
Address [1] 251520 0
Gosford Hospital
PO Box 361
Gosford. NSW 2250
Country [1] 251520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258289 0
Harbour HREC
Ethics committee address [1] 258289 0
Research Business Unit
Level 2, Building 51
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Ethics committee country [1] 258289 0
Australia
Date submitted for ethics approval [1] 258289 0
16/11/2009
Approval date [1] 258289 0
10/06/2010
Ethics approval number [1] 258289 0
Protocol 0911-318M(CTN)

Summary
Brief summary
The aims of this study will address the following hypotheses, that:

The daily topical application of EMLA cream to the wound bed reduces pain levels for patients with a chronic leg ulcer.
Improvement in pain levels will be associated with reduced need for oral analgesia, particularly opiates.
Topical application of EMLA cream to the wound bed decreases healing time for chronic leg ulcers
Improvement in leg ulcer pain and/or wound healing will be associated with gains in health-related quality of life.


Hypothesis
Our hypothesis is that the daily topical application of EMLA 5% cream to the wound bed of painful chronic leg ulcers as the primary dressing, will reduce wound-related pain and analgesic requirements, and improve the quality of life for patients with painful chronic leg ulcers. The secondary outcome measure is decreased wound healing times. As the primary outcome measure is pain reduction, this study will investigate painful chronic leg ulcers of varying aetiology, including venous, arterial and/or mixed ulceration.
Trial website
Trial related presentations / publications
Purcell A, Buckley T, Fethney J, King J, Moyle W, Marshall AP. The effectiveness of EMLA® as a primary dressing on painful chronic leg ulcers - a pilot randomised controlled trial. Adv Skin Wound Care. 2017;30(8):354-363.

Purcell A, Buckley T, Fethney J, King J, Moyle W, Marshall AP. The effectiveness of EMLA® as a primary dressing on painful chronic leg ulcers: effects on wound healing and health-related quality of life. Int J Low Extrem Wounds. 2017;16(3):163-172.
Public notes

Contacts
Principal investigator
Name 30619 0
Ms Anne Purcell
Address 30619 0
Central Coast Local Health District
Community Nursing Service
38A Pacific Hwy
Wyong NSW 2259
Country 30619 0
Australia
Phone 30619 0
+61414192868
Fax 30619 0
Email 30619 0
[email protected]
Contact person for public queries
Name 13866 0
Ms Anne Purcell
Address 13866 0
Central Coast Community Nursing Service
Wyong Community Health Center
38A Pacific Hwy
Wyong NSW 2259
Country 13866 0
Australia
Phone 13866 0
+61 414192868
Fax 13866 0
Email 13866 0
[email protected]
Contact person for scientific queries
Name 4794 0
Ms Anne Purcell
Address 4794 0
Central Coast Community Nursing Service
Wyong Community Health Center
38A Pacific Hwy
Wyong NSW 2259
Country 4794 0
Australia
Phone 4794 0
+61 414192868
Fax 4794 0
Email 4794 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
SourceTitleYear of PublicationDOI
EmbaseEutectic mixture of local anaesthetics (EMLA) as a primary dressing on painful chronic leg ulcers: A pilot randomised controlled trial.2018https://dx.doi.org/10.1186/s40814-018-0312-6
N.B. These documents automatically identified may not have been verified by the study sponsor.