Table 1 Inclusion and exclusion criteria and rational for inclusion in study
Rationale | |
|---|---|
Inclusion criteria | |
1. One or more chronic lower leg ulcer(s) of at least 6 weeks duration | A chronic wound is defined as one which has not followed the expected path of healing when related to time, appearance and responses to optimum wound management and is often demonstrated when a wound has not shown signs of healing within a 6-week period [54] |
2. Wound size up to 100 cm2 in size in total | The maximum wound size of 100 cm2 was selected due to the maximum dose/surface area ratio of 1–2 g EMLA® to 10 cm2 of wound surface area, the recommended maximum dose being 10 g. This dose/surface area ratio is recommended for the application of EMLA® when used for the debridement of non-viable tissue from a leg ulcer [55] |
3. Patients with low to moderate wound exudate | This will enable the EMLA® to remain on the wound bed over 24 h and not run off the wound due to excessive wound exudate |
4. Numerical rating scale (NRS) pain score ≥ 4 at assessment and/or within the previous week | WRP ≥ NRS of 4 can indicate uncontrolled pain during or after dressing change which may require a change of management [56] |
5. Patients currently requiring oral analgesics due to previously reported wound-related pain | Individuals with WRP are often prescribed oral analgesia indicating their level of pain is significant |
6. Patients ≥ 18 years of age | The prevalence of CLUs increases with age thus the prevalence in those < 18 years of age is low [57] |
7. Patients with the capacity (cognition and/or language) | Participants in this study should be capable of providing well-informed and considered consent |
8. Patients have the capacity to attend the CCCNS Procedure Clinics. The exception is participants requiring visits on weekends and public holidays; health centres are closed at these times. This was in accordance with the NSCCH Home Safety Procedures for Community Nursing, CCH (PR2007_016). | Continuity of care |
Exclusion criteria | |
1. Patients scheduled for leg amputation | Amputation of the lower limb with a CLU would negate the need for wound management |
2. History of peripheral sensory neuropathy (PSN) of the feet Modification: After 6 July, 2011, patients with painful peripheral neuropathy were no longer excluded | This study includes painful CLUs. Individuals with PSN often do not experience any peripheral sensation in their feet or lower legs [58] Patients with painful peripheral neuropathy can also experience painful WRP |
3. Patients that have had or require the use of EMLA® for debridement of the wound bed within the previous 4 weeks before recruitment Modification: After 9 February 2011, patients were only excluded if they had EMLA® applied for debridement of the wound bed within the previous week | The introduction of EMLA® within 4 weeks may influence baseline data The half-life lignocaine and prilocaine is 65–150 and 10–150 min, respectively, a similar half-live of their intravenous counterparts [55, 59] |
4. Patients with suspected wound malignancy or pyoderma gangrenosum confirmed by biopsy | The management of leg ulceration caused by malignancy or pyoderma gangrenosum requires different management than ulcerations due to venous, arterial or diabetic aetiology |
5. Patients with diagnosed localised or spreading clinical wound infection | Management of wound infection requires the introduction of strategies that may influence the individual’s pain levels beyond the capabilities of the primary dressing |
6. End-stage palliative care patients | End-stage palliative patients often require increased use of analgesics for palliation, thus the effectiveness of an intervention may be masked |
7. Patients where EMLA® is contraindicated or cautioned | To reduce potential participant harm [55] |