The Effectiveness of EMLA as a Primary Dressing on Painful Chronic Leg Ulcers: Effects on Wound Healing and Health-Related Quality of Life

Abstract

This study aimed to evaluate the effect of EMLA 5% cream applied to painful chronic leg ulcers (CLUs) as a primary dressing on wound healing and health-related quality of life (HRQoL). A pilot, parallel-group, nonblinded, randomized controlled trial was conducted in 6 community nursing procedure clinics in New South Wales, Australia. A total of 60 participants with painful CLUs of varied etiology were randomly assigned to the intervention (EMLA daily for 4 weeks as a primary dressing, followed by usual care) or usual care only. Wound size and HRQoL were measured at baseline, end of the intervention period (week 4), and week 12. At baseline, wound sizes were similar for both the intervention and control groups. During the intervention period, there was no significant difference in wound sizes between groups (intervention group: median (cm) = 2.4, IQR = 1.3-12.7; control group: median (cm) = 5.0, IQR = 2.5-9.9; P = .05). Mean HRQoL scores for all subscales at baseline and weeks 4 and 12 were similar between groups except for Wellbeing, which was significantly higher in the intervention group at the end of the 4-week intervention period (intervention group: mean = 52.41, SD = 24.50; control group: mean = 38.15, SD = 21.25; P = .03; d = 0.62). The trial findings suggest that daily applications of EMLA as a primary dressing do not inhibit wound healing and may improve patient well-being. Studies with larger samples are required to more comprehensively evaluate the impact of this treatment on wound healing and HRQoL.

Qualidade de vida de pessoas com feridas crônicas

“…These results demonstrate that the presence of cutaneous wounds has negative effects on well-being, regardless of the place of care, and is directly associated with the emotional response to physiological conditions and health-related aspects. (11)(12)(13)(14) The well-being domain includes the level of anxiety in relation to the outcome of the injury and can be influenced by the presence of symptoms, the treatment methods or any changes in physical, psychological and social functioning. (10,13) Among the clinical characteristics, the variable "duration of wound" was associated with the domain "social life" in the outpatient environment.…”

“…(11)(12)(13)(14) The well-being domain includes the level of anxiety in relation to the outcome of the injury and can be influenced by the presence of symptoms, the treatment methods or any changes in physical, psychological and social functioning. (10,13) Among the clinical characteristics, the variable "duration of wound" was associated with the domain "social life" in the outpatient environment. This result may be related to the prevalence of injuries with up to six months, which can be associated with a lower degree of adaptation or acceptance and fear of being stigmatized, leading patients to develop problems related to social isolation and fear of exposing and even looking at the wound.…”

“…(15) It is necessary to use pharmacological and non-pharmacological strategies that allow proper wound management by providing healing, pain relief and, consequently, improvement in QoL. (13) Care for people with wounds requires special attention from health professionals. The role of the nurse stomatherapist should be highlighted, since this professional has the knowledge, skills and managerial competencies to care for any type of injury, is an essential part of the health team, and should assume the functions of this area, providing better results in the individual and collective scope and, consequently, in QoL.…”

Understanding the Hawthorne effect in wound research—A scoping review

“…34 Also related to the description of wound pain, King 43 claimed the likelihood of HE on observational data. Other subjective outcomes reported by participants are quality-of-life score 44 and users' perception of an intervention's utility. 45 The occurrence of the HE was also believed to be derived from the lack of blinding.…”

“…HE in the reviewed articles was present as a passing mention and related to three purposes: justifying an aspect of the research design, 23,24,[26][27][28][29][30]53 defending unexpected findings, [32][33][34][35][36][38][39][40]44,46,54,55 and acknowledging a deficit of conducting an open-label study. 37,42,47,56,57 Regardless of the purpose, the term HE was referred to briefly and lacked definition in most of the reviewed articles.…”