Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. EMLA cream as a topical anesthetic for the repeated mechanical debridement of venous leg ulcers: a double-blind, placebo-controlled study. Repeated treatment with lidocaine/prilocaine cream (EMLA) as a topical anaesthetic for the cleansing of venous leg ulcers. A controlled study. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Randomised, comparative study of three primary dressings for the treatment of venous ulcers. Pentoxifylline in the treatment of venous leg ulcers. Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial. Randomised, double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers. Analgesic efficacy of an ibuprofen-releasing foam dressing compared with local best practice for painful exuding wounds.
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. 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. 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. 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. 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. A double-blind, placebo-controlled study was carried out in 12 patients suffering from chronic venous insufficiency and persistent leg ulcers to assess the efficacy of pentoxifylline treatment as an adjunct to compression bandaging in the conservative management of venous leg ulcers. Six patients were allocated at random to receive twice-daily infusions of 200 mg pentoxifylline intravenously and 400 mg pentoxifylline orally 3-times daily for 7 days then 400 mg oral doses 3-times daily for a further 60 days. The control group received matching placebo in an identical regimen. Treatment outcome was assessed by changes between the start and end of the study in venous ulcer surface area, and continuous wave Doppler ultrasound was used to monitor ankle/arm systolic pressure ratio, venous pressure at the ankle, valvular competence and possible venous reflux at intervals throughout the study period. The results showed that in the patients treated with pentoxifylline complete ulcer healing took place in 4 out of 6 and there was a significant reduction in mean ulcer surface area. In the control group, complete ulcer healing was recorded in 1 out of 6 patient only and the ulcer area was only moderately reduced in the others. There was no statistically significant differences between the two groups in the variables monitored by Doppler ultrasound but the difference between treatment outcome was significant. Treatment was well-tolerated. Several small studies have indicated that the systemic administration of pentoxifylline may accelerate healing of venous leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of pentoxifylline on healing. The study used a prospective, randomized, double-blind, parallel group placebo controlled design in a multicenter outpatient setting. Patients with one or more venous ulcer were enrolled, with all patients receiving standardized compression bandaging for treatment for their ulcers. Patients were also randomized to receive either pentoxifylline 400 mg, pentoxifylline 800 mg (two 400 mg tablets), or placebo tablets three times a day for up to 24 weeks. The main outcome measure was time to complete healing of all leg ulcers, using life table analysis. The study was completed as planned in 131 patients. Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to complete healing was 100, 83, and 71 days for placebo, pentoxifylline 400 mg, and pentoxifylline 800 mg three times a day, respectively. Over half of all patients were ulcer free at week 16 (placebo) and at week 12 in both pentoxifylline groups. Whereas the placebo group had only achieved complete healing in half of the cases by week 16, all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely. Treatment with pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups. Complete wound closure occurred at least 4 weeks earlier in the majority of patients treated with pentoxifylline by comparison to placebo. A higher dose of pentoxifylline (800 mg three times a day) was more effective than the lower dose. We conclude that pentoxifylline is effective in accelerating healing of leg ulcers. To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.
                Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.
                Leg ulcer clinics of a teaching and a district general hospital in southern Scotland.
                200 patients with confirmed venous ulcers and in whom other major causal factors were excluded. Interventions: Pentoxifylline 400 mg three times daily or placebo.
                Complete healing (full epithelialisation) of all ulcers on the trial leg.
                Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.
                The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance. 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.
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.