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Eutectic mixture of local anaesthetics (EMLA®) as a primary dressing on painful chronic leg ulcers: a pilot randomised controlled trial
Open accessAbstract
The physical, occupational, social and psychological impact of chronic leg ulcers (CLUs) on an individual is considerable. Wound-related pain (WRP), the most common symptom, is frequently reported as moderate to severe and mostly occurs at dressing change. WRP pain may not be alleviated by oral analgesics alone. Persistent poorly controlled leg ulcer pain can negatively impact wound healing and health-related quality of life (HRQoL). A pilot, parallel group, non-blinded, randomised controlled trial was conducted in six procedure clinics located in a public community nursing service in New South Wales, Australia to evaluate eutectic mixture of local anaesthetics (EMLA®) on painful CLUs when used as a primary dressing. The primary objective was to assess feasibility by using pre-determined criteria: at least 80% recruitment rate, 80% retention rate and 80% adherence to the study protocol. Key eligibility criteria were that participants had a painful CLU no larger than 100 cm2, a numerical rating scale (NRS) wound-related pain intensity score equal to or greater than 4, low to moderate exudate, no contraindications to EMLA® and capacity to consent. One hundred and seven patients with painful CLUs were screened for eligibility; 56% (n = 60) were eligible and consented to participate in the study. Participants were randomly assigned to the intervention (n = 30) or control (n = 30) groups. The intervention group received a measured dose of the topical anaesthetic EMLA® 5% cream daily as a primary dressing for 4 weeks followed by usual wound management for a further 8 weeks. The control group received usual wound management. Participants and investigators were not blinded to the treatment. WRP was measured at every dressing change. Wound healing and HRQoL were measured at baseline, 4 and 12 weeks. Recruitment rate was lower than expected which likely meant patients were missed. Study retention rate was 90% (n = 54). Intervention fidelity was impacted by availability of resources and patient factors such as increased WRP. This study identified that a larger randomised controlled trial investigating EMLA® applied as a primary dressing on painful chronic leg ulcers is feasible with modifications to the study protocol. Australian New Zealand Clinical Trials Register: Registered 16 December, 2009
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Some pilot trial publications have effectively reported pilot trial findings in a similar format to GRADE Summary of Findings tables.
“some pilot trial publications have effectively reported pilot trial findings in a similar format [32–35].”
From Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting (2023) · cites this paper as [32]
The Discussion’s Table 5 summarizes pilot-trial feasibility findings in rows for topics such as recruitment and retention, with columns for challenges, solutions, and recommendations. That supports the claim that findings were reported in a summary-table format, but the table does not present the comparative outcome estimates or certainty assessments characteristic of a GRADE Summary of Findings table. No page number is available in our copy. (LLM, conf=0.78)
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Metadata
- Authors
- Purcell, A., Buckley, T., King, J., Moyle, W., & Marshall, A. P.
- Affiliations
- Griffith University (AU)
- The University of Sydney (AU)
- Corresponding author
- Purcell, Anne
- Venue
- Pilot and Feasibility Studies
- Published
- 2018-07-07
- Volume
- 4
- Issue
- 1
- Pages
- 123-123
- ISSN
- 2055-5784 (ISSN-L)
- PMC
- PMC6035424
- OpenAlex
- W2817692153
- Cited by
- 6
- References
- 66
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 1 · 2020: 1 · 2019: 1
- FWCI
- 0.43
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Pilot and Feasibility Studies (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Griffith Research Online (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- New South Wales (NSW) Health Nursing and Midwifery Innovation Scholarship
- Australian Wound Management Research Foundation Grant
- Central Coast Health Research Advisory Committee CHARM Research Grant
- Topics
- Health Sciences › Medicine › Surgery › Wound Healing and Treatments
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Anesthesia and Pain Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Keywords
- EMLA, chronic leg ulcers, topical anesthesia, wound healing, health-related quality of life, feasibility, community nursing
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