The safety and efficacy of three-layer (3L) tubular bandaging as a treatment for venous ulcer healing has not been evaluated despite its use in many clinical settings to treat people with venous leg ulcers. We evaluated the safety and efficacy of 3L tubular bandage compared with short-stretch compression bandage to heal venous ulcers in a multicenter, open-label, parallel-group, randomized controlled trial. We randomized 45 patients with venous leg ulcers of up to 20 cm(2) area and an ankle brachial pressure index of >0.8 from hospital outpatient wound clinics in Victoria and Queensland, Australia. We measured time to healing and percentage reduction of wound size from baseline to week 12. Secondary outcomes were proportion of ulcers healed, self-reported compliance of compression bandage, and health-related quality of life, costs, recurrence rates, and adverse events. A total of 27 ulcers healed, the proportion of healed ulcers was higher for the 3L group (17/23 [74%] vs. 10/22 [46%]) (p = 0.05). Reported bandage tolerance at all treatment visits was 21 (91%) in 3L group vs. 17 (73%) (p = 0.10). There was no difference between the groups in adverse events. Costs were substantially less in 3L group.
This randomized, double-blind study evaluated the efficacy and safety of a short, 5-day course of telithromycin, a new ketolide antibacterial, compared with a standard 10-day course of amoxicillin/clavulanate, in the treatment of acute exacerbations of chronic bronchitis (AECB). The study enrolled 325 adult patients with AECB and a history of chronic obstructive pulmonary disease (COPD). Patients received either telithromycin 800 mg once daily (qd) for 5 days (followed by placebo for 5 days) or amoxicillin/clavulanate 500/125 mg three times daily (tid) for 10 days. Clinical cure rates for telithromycin post-therapy (Days 17-21, test-of-cure) and late post-therapy (Days 31-36) were 86.1 and 78.1%, respectively; 82.1 and 75.0% for amoxicillin/clavulanate. Excellent clinical cure rates were also observed for high-risk patients. Bacteriologic outcome was satisfactory for 69.2% of telithromycin recipients vs 70.0% for amoxicillin/clavulanate recipients. Both treatments were generally well tolerated, although the frequency of drug-related adverse events was almost two-fold higher for amoxicillin/clavulanate (25.0 vs. 13.1%). Thus, a 5-day course of telithromycin 800 mg qd is an effective and well-tolerated alternative to a standard 10-day course of amoxicillin/clavulanate 500/125 mg tid for first-line empiric treatment of AECB in adults with COPD.
BackgroundVenous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing.Methods/designThis randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.DiscussionThe ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12614000293662
Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population. Despite improvements in wound care, some wounds will not heal and they present a significant challenge for patients and health care providers. A multi-centre cohort study was conducted to evaluate the effectiveness and safety of a synthetic, extracellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal venous or mixed leg ulcers. Primary effectiveness criteria were (i) reduction in wound size evaluated by percentage change in wound area and (ii) healing assessed by number of patients healed by end of the 12 week study. Pain reduction was assessed as a secondary effectiveness criteria using VAS. A total of 45 patients completed the study and no difference was observed between cohorts for treatment frequency. Healing was achieved in 35·6% and wound size decreased in 93·3% of patients. Median wound area percentage reduction was 70·8%. Over 50% of patients reported pain on first visit and 87·0% of these reported no pain at the end of the study. Median time to first reporting of no pain was 14 days after treatment initiation. The authors consider the extracellular synthetic matrix protein an effective and safe adjunct to standard care in the treatment of hard-to-heal leg ulcers.
One hundred and twenty-five outpatients with clinical symptoms of an acute bacterial exacerbation of chronic bronchitis were enrolled in a multicentre, double-blind, randomized clinical trial to compare the efficacy and safety of oral clarithromycin and ampicillin. Only those patients presenting with pathogens cultured from pre-treatment specimens susceptible to both study drugs were included in the study; beta-lactamase producing strains were excluded. Sixty patients received clarithromycin 250 mg 12-hourly and 65 had ampicillin 250 mg 6-hourly for 7-14 days. Clinical and bacteriological evaluations were performed pre-treatment, during treatment, and post-treatment within 48 h of cessation of therapy. All adverse events reported were evaluated. Twenty patients from the clarithromycin group and 24 from the ampicillin group were withdrawn from the study when no pathogen was isolated from the pre-treatment specimens. Twenty-eight patients who received clarithromycin and 23 who received ampicillin were evaluable for clinical and bacteriological efficacy. Both treatment groups were similar with respect to clinical and bacteriological response rates. The clinical cure rate for clarithromycin was 96% (27/28) compared with 91% (21/23) for the ampicillin group. Clarithromycin achieved a bacteriological cure rate of 96% (27/28) compared with 100% (23/23) for the ampicillin group. Adverse events, which were generally mild and associated with the digestive system, were reported by 11.7% of patients receiving clarithromycin and 1.5% of patients receiving ampicillin. Adverse events caused two patients in each group to discontinue treatment. Laboratory profiles for both groups were unremarkable throughout treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
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