EMLA cream as a topical anesthetic for the repeated mechanical debridement of venous leg ulcers: a double-blind, placebo-controlled study. Cryopreserved and lyophilized cultured epidermal allografts in the treatment of leg ulcers: a pilot study. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. Randomised, comparative study of three primary dressings for the treatment of venous ulcers. A randomized controlled trial of electromagnetic therapy in the primary care management of venous leg ulceration. Repeated treatment with lidocaine/prilocaine cream (EMLA) as a topical anaesthetic for the cleansing of venous leg ulcers. A controlled study. Analgesic efficacy of an ibuprofen-releasing foam dressing compared with local best practice for painful exuding wounds. Comparing a foam composite to a hydrocellular foam dressing in the management of venous leg ulcers: a controlled clinical study. The healing properties of Promogran in venous leg ulcers. The influence of dressings on venous ulcer healing--a randomised trial.
A granulating surface is important for skin grafting and healing of leg ulcers. Mechanical debridement to remove necrotic tissue often must be stopped before completion because of pain.
                Our purpose was to assess the effect of EMLA cream on the number of debridements required to obtain a clean ulcer and on pain during debridement and to determine its safety after repeated doses.
                In this randomized double-blind, placebo-controlled study, 69 patients with venous leg ulcers received cream before debridement until a clean ulcer was obtained (or a maximum of 15 debridements).
                EMLA decreased the median number of debridements required for a clean ulcer (EMLA 11.5, placebo >15; P = .019) and decreased pain by 50% (P = .003). Plasma levels of lidocaine, prilocaine, and their main metabolites were low without any apparent accumulation.
                EMLA produces effective pain relief for the debridement of leg ulcers and shortens the time to a clean ulcer. In the conservative therapy of venous leg ulcers modern types of dressings are used most frequently. In the past 20 years 'active wound dressings' - cultured epidermal keratinocytes as autografts and allografts - were also introduced in the management of leg ulcers.
                The aim of our study was to compare the effect of cryopreserved and lyophilized cultured epidermal allografts in the treatment of venous leg ulcers. Evaluation of the therapy was documented as photodocumentation, planimetry, healing time and evaluation of pain relief over a 3-month period after application. Fifty patients with venous leg ulcers were selected. Twenty-five patients (group I) were treated with cryopreserved keratinocytes and 25 (group II) with lyophilized keratinocytes.
                The final evaluation 3 months after the application of allografts showed 84% of healed ulcers in group I and 80% in group II. The number of healed ulcers and the healing rate both showed no statistically significant differences. The size of the ulcer was reduced by half during the first week in both groups. The size differences during the first week are statistically significant in both groups and they are comparable (P < 0.001). The intensity of the pain was statistically significantly reduced during the first week after application in both groups (P < 0.001).
                The cryopreserved and lyophilized cultured allografts are comparable in healing rate, course of healing and relief of pain, and also in planimetric changes during the healing of venous leg ulcers. Lyophilized allografts are more convenient for routine use than cryopreserved allografts as they can be stored at room temperature. These results could give rise to the more frequent use of lyophilized allografts in slow-healing venous leg ulcers. The analgesic effect of EMLA 5% cream for surgical cleansing of leg ulcers was investigated in an open study and in a double-blind comparison with placebo. Eighty patients with ulcers of venous or arterial origin participated. The cream was applied under occlusion and removed before cleansing. Plasma concentrations of lidocaine and prilocaine were assessed. The maximum individual concentrations were 0.8 microgram/ml for lidocaine and 0.08 microgram/ml for prilocaine. Pain was assessed according to a verbal rating scale and on a 100 mm visual analogue scale. The median VAS pain scores for EMLA and placebo were 18.5 and 84 mm (p less than 0.01). There were no severe adverse reactions. The results show that there is a need for pain control in surgical debridement of leg ulcers and that EMLA cream gives satisfactory analgesia for this procedure. This multicentre, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of using Emla (lignocaine/prilocaine) anaesthetic cream to achieve pain control during sharp debridement of chronic leg ulcers of arterial, venous or arteriovenous aetiology. A total of 101 patients (51 Emla, 50 placebo), aged 29-99 years, who had experienced pain associated with previous debridement were included. Patients with an amide anaesthetic allergy, anaesthetic diabetic ulcers, or ulcers > 50 cm2 were excluded. Debridement was initiated approximately 30 minutes after the application of a thick layer of Emla or placebo cream to an ulcer occluded with a plastic wrap. The patient and investigator assessed the pain associated with debridement on a 100 mm visual analogue scale (VAS). The median patient VAS scores were 18 mm and 53.5 mm in the Emla and placebo groups, respectively (p < 0.0001). The corresponding investigator values in the two groups were 20 mm and 49.5 mm, respectively (p = 0.004). Local reactions were mainly transient and mild, and were observed in roughly the same percentage of placebo and Emla-treated patients. After a 30-minute application Emla cream significantly reduced the pain of debridement compared with the placebo. In this article, we describe a randomised trial in which two established primary dressings - Comfeel (Coloplast, UK) and Granuflex improved formulation (Convatec, UK) - were compared to Cutinova foam (Beiersdorf Medical, UK) in the management of venous leg ulcers. Patients that met the study trial criteria were randomised to receive one of the three primary dressings. All ulcers were secondarily bandaged with Comprilan (Beiersdorf Medical, UK) short-stretch compression. The three dressings were compared in terms of their ability to promote ulcer healing (closure rate and healing rate) and reduce the prevalence and severity of ulcer-associated pain, over a 12-week period. The ease with which dressings could be used in a busy outpatient clinic setting was also considered. On enrollment, groups were well matched in terms of all of the patient and ulcer parameters studies. Six patients were withdrawn for reasons unrelated to study dressings or trial procedures. Following non-parametric analysis of the study data, the three dressings were found to be equally effective at promoting ulcer healing and alleviating ulcer-associated pain. Study personnel rated Cutinova Foam as easy, if not easier, to use than Comfeel or Granuflex. This study suggests that Cutinova Foam is as safe and effective as both Comfeel and Granuflex, in the treatment of venous leg ulcers. The aim was to establish the potential efficacy, tolerability and side-effect profile of electromagnetic therapy as an adjunct to conventional dressings in the treatment of venous leg ulcers.
                A prospective, randomized, double blind controlled clinical trial was carried out in a dedicated leg ulcer clinic based in one urban general practice. Nineteen patients with leg ulcers of confirmed venous aetiology were assessed. The main outcome measures were rate and scale of venous leg ulcer healing, changes in patient-reported pain levels, quality of life, degree of mobility, side effect profile and acceptability to patients and staff.
                Sixty-eight per cent of patients attending this dedicated clinic achieved improvements in the size of their ulcer (4, 21%, healed fully) and in reduced pain levels (P < 0.05) during the trial, despite the chronicity of ulcer histories. Patients treated with electromagnetic therapy at 800 Hz were found at day 50 to have significantly greater healing (P < 0.05) and pain control (P < 0.05) than placebo therapy or treatment with 600 Hz. All patients reported improved mobility at the end of the study. The electromagnetic therapy was well tolerated by patients, with no differences between groups in reporting adverse events, and proved acceptable to staff.
                Despite the small numbers in this pilot study, electromagnetic therapy provided significant gains in the healing of venous leg ulcers and reduction in pain. Repeated topical analgesia with EMLA 5% cream prior to the cleansing of venous leg ulcers was studied. Patients were randomly allocated to a series of 8 treatments with EMLA (n = 22) or to a control group (n = 21). A thick layer of the cream was applied to the ulcers for 30 min. At each of the 8 treatments, local reactions were assessed on a 4-point scale and pain from ulcer cleansing on a visual analogue scale. At the first and the last treatment the area of the ulcer was determined by mapping, a sample for a bacterial culture was taken and the amount of dead tissue, slough and granulation tissue present was assessed. Treatment with EMLA for 30 min significantly decreased the pain from cleansing of the leg ulcers and the frequency of post-cleansing pain. The analgesic effect remained unchanged with successive treatments. Repeated treatment with EMLA in leg ulcers would appear to be safe, as indicated by the absence of any serious untoward events. No statistically significant differences in local reactions or adverse effects on granulation tissue, ulcer area or bacterial flora were observed in the EMLA-treated patients compared with the control patients. To examine if wound aetiology has an effect on the pain-relieving properties of an ibuprofen-releasing foam dressing, which was previously shown to reduce pain in wounds of various aetiologies, compared with local best practice (LBP).
                This was a secondary analysis of data from a multicentre, randomised, parallel group trial of patients with painful exuding wounds of various aetiologies. Wound aetiology was determined at enrolment. Of 853 patients enrolled into the trial, 688 belonged to a wound aetiology subgroup that included >25 patients and were included in the analysis reported here. Patients were randomised to a dressing containing 112.5mg of ibuprofen (ibuprofen foam) or to LBP for 5 days. Patients recorded pain relief and pain intensity daily. The main endpoint was the proportion of patients who, from day 1 to day 5, reported a summed pain relief score >50% of the total maximum pain relief score (TOTPARD5>50%) and the corresponding number needed to treat (NNT) for each wound aetiology subgroup. Further analyses included the proportion of patients who, on a daily basis, reported pain relief >50% of the maximum daily pain relief, the proportion of patients who, on day 5, experienced a reduction in pain intensity of >50% of the maximum score (PIDD5>50%), and if PIDD5>50% was related to baseline pain intensity.
                Patients were categorised by the following five wound types: arterial, venous, and mixed arterial-venous leg ulcers, vasculitis and traumatic ulcers. The ibuprofen foam dressing was associated with significantly greater pain relief than LBP in all different wound aetiology subgroups, whether chronic or traumatic (acute). Overall, TOTPARD5>50% was 55% in the ibuprofen foam group and 24% in the LBP group (p<0.0001; NNT, 3.2). The pain intensity evaluations revealed similar results in favour of ibuprofen foam compared with LBP. No correlation was observed between PIDD5>50 and initial pain intensity.
                In this study, the ibuprofen foam dressing was shown to consistently relieve wound pain in exuding wounds of various aetiologies, irrespective of basal pain intensity. The data suggest that local pain relief by an ibuprofen foam dressing is possible in the most common, painful, exuding, chronic and acute/traumatic wounds and so is a safer alternative to systemic pain treatment. Venous leg ulcers are the most prevalent form of chronic wounds in the Western world. The principles of moist wound healing coupled with the use of graduated compression bandaging have become the cornerstone of treatment for venous leg ulcers but not all moist dressings are alike. To compare the attributes of a foam composite dressing with those of a hydrocellular foam dressing in the management of venous leg ulcers, a prospective, randomized, comparative 12-week study was conducted in 15 centers in the US, Canada, France, Germany, and the UK. Dressings were changed and compression bandages applied per manufacturer recommendations and dressing performance was assessed at every dressing change and at the final evaluation. Patients with venous ulcers were randomized to treatment for 12 weeks with either hydrocellular foam (n = 52) or foam composite (n = 55) dressing. Healing differences between the groups were not statistically significant, with 36% of patients using foam composite dressing healed in a mean of 66 days and 39% of patients using hydrocellular foam dressing healed in a mean of 73 days. However, the foam composite dressing performed significantly better than the hydrocellular foam dressing with regard to condition of the periwound skin - 55% of patients in the foam composite group having healed or markedly improved surrounding skin compared to 37% of patients using hydrocellular foam (P = 0.03). The foam composite dressing was rated significantly better than the hydrocellular foam dressing ("very good" to "excellent") in level of satisfaction with conformability (87% and 75%, respectively, P = 0.05); being non-sensitizing (73% and 52%, respectively, P = 0.02); and ease of application (93% and 81%, respectively, P = 0.01). The findings reported in this study suggest that the foam composite dressing offers significant improvements in the quality of life of patients with venous leg ulcers as well as for their caregivers. To evaluate the healing rate of venous leg ulcers treated with Promogran.
                Patients with stagnating venous leg ulcers were recruited. Target wounds were > or = 2 cm but < or = 10 cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed.
                Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p = 0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p = 0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p = 0.079). Surface area decreased, on average, by 36.5 +/- 11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +/- 10.9% (median decrease: 82.4%) in the Promogran group (p < 0.001). A < or = 20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p = 0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups.
                The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care. To assess the effect of different dressings on venous ulcer healing.
                A randomised clinical trial.
                Patients were randomised to treatment with one of three dressings: a zinc oxide impregnated bandage, a zinc oxide impregnated stockingette, or an alginate dressing. All patients were treated as outpatients and had compression bandaging with two minimal stretch bandages (Elastocrepe) and a stockingette (Tubigrip) to keep the bandages in place.
                One hundred and thirteen patients (133 ulcerated limbs) with chronic ulceration of the leg due to venous disease alone, and attending Fremantle Hospital Leg Ulcer Clinic, Western Australia were entered into the study. Healing was measured as complete healing of the ulcerated limb or failure of the limb to heal within 9 months.
                There was no significant difference between the three groups in ulcer size, duration, and other parameters compared. Healing was affected significantly by ulcer size and which leg was ulcerated. There was significantly faster healing with the paste bandage.
                The use of a paste bandage significantly improved the healing of chronic venous ulcers when used in combination with compression bandaging, and compared to an alginate dressing and a zinc oxide impregnated stockingette.
There is some evidence to suggest that ibuprofen dressings may offer pain relief to people with painful venous leg ulcers. EMLA (5%) appears to provide effective pain relief during the debridement of venous leg ulcers. Further research should consider standardised pain assessment methods and assess both the effect on ulcer healing and the impact of long term use of these treatments.