orabase and Leg-Ulcer

The performance and safety of Exufiber® gelling fibre and Aquacel® Extra™ Hydrofiber® wound dressings were compared for the management of chronic, exuding leg ulcers. The 6-week study (≤ 24 weeks in a subgroup of subjects) was a randomised, open-label, parallel-group, multicentre, non-inferiority design. Adults (n = 248, 30-97 years of age) were randomised to either Exufiber® or Aquacel® Extra™ dressing. The dressings were applied at baseline and evaluations of wound condition and performance of the dressing were recorded at 1, 2, 3, 4, and 6 weeks. The primary efficacy endpoint was the percentage reduction in wound area at 6 weeks relative to baseline, in the per protocol (PP) population. A median relative reduction of 50% for Exufiber® (n = 100) vs 42% for Aquacel® Extra™ (n = 107) was demonstrated in the PP population (P = 0.093) and confirmed in the intention-to-treat population. As the mean and 95% confidence interval for the difference in relative wound area reduction between groups at 6 weeks was -29.4% (-63.5; 3.2), and the lower limit did not exceed 12%, non-inferiority of Exufiber® was concluded. Both dressings were well tolerated and no safety concerns were identified in both groups. Clinicians' satisfaction with the dressings was higher for Exufiber® than for Aquacel® Extra™ in terms of ease of use and management of exudate, slough, and blood.

Topics: Adult; Bandages; Carboxymethylcellulose Sodium; Humans; Leg Ulcer; Prospective Studies; Treatment Outcome; Wound Healing

To evaluate the efficacy, tolerance and acceptability of Urgotul and DuoDERM E dressings in the local management of venous or mixed-aetiology leg ulcers.. This was a prospective multicentre randomised phase IV clinical trial conducted open-label in parallel groups. It involved 20 investigating centres, including hospital dermatology and vascular medicine departments, and private practices. Dermatologists and angiologists/phlebologists took part. Subjects were adult, non-immunosuppressed patients presenting with a non-infected, non-malignant leg ulcer of predominantly venous origin (ABPI > 0.8). Ulcers were between 4cm2 and 40cm2 in size, with granulation tissue covering more than 50% of their surface area. Ulcer duration ranged from three to 18 months. Patients were followed-up by the investigating physician for eight weeks on a weekly basis; this included clinical examination, wound area tracings and photographs. Nurses (hospital or visiting) assessed exudate volume and clinical appearance at dressing changes.. Ninety-one patients were included: 47 in the Urgotul group and 44 in the DuoDERM E group. Baseline patient demographic data and wound characteristics were comparable in the two groups. After eight weeks of treatment wound surface area had reduced by a mean of 61.3% in the Urgotul group and 52.1% in the DuoDERM E group (NS); dressings were changed more frequently in the DuoDERM E group (2.54 +/- 0.57 times per week versus 2.31 +/- 0.45 in the Urgotul group, p = 0.047). Thirty-three local adverse events were recorded in 27 patients: 10 in the Urgotul group and 23 in the DuoDERM E group (p = 0.039). Nurses reported better acceptability for the Urgotul dressing, based on pain on removal, maceration and odour (p < 0.0001).. Both dressings showed similar efficacy for the local treatment of venous leg ulcers. Nevertheless, medical and nursing staff reported better tolerance and acceptability for the Urgotul dressing.

Topics: Adult; Aged; Aged, 80 and over; Bandages, Hydrocolloid; Carboxymethylcellulose Sodium; Colloids; Exudates and Transudates; Female; Humans; Leg Ulcer; Male; Middle Aged; Nursing Assessment; Nursing Evaluation Research; Odorants; Patient Acceptance of Health Care; Prospective Studies; Skin Care; Treatment Outcome; Wound Healing

Twenty-two patients with chronic ulcers of the lower limb were treated with 'Varihesive', a modified form of 'Stomahesive'. The results showed that granulation was stimulated by the dressing, and no side-effects were encountered. The treatment is considered to be a useful adjunct to routine supportive measures. I should like to thank E.R. Squibb & Sons for providing the material for this study.

Topics: Aged; Bandages; Carboxymethylcellulose Sodium; Chronic Disease; Clinical Trials as Topic; Female; Gelatin; Granulation Tissue; Humans; Leg Ulcer; Male; Middle Aged; Pectins

Topics: Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Female; Foot Ulcer; Humans; Leg Ulcer; Male; Middle Aged; Wound Healing

Topics: Carboxymethylcellulose Sodium; Disease Progression; Humans; Leg Ulcer; Male; Middle Aged; Multiple Sclerosis, Chronic Progressive; Wound Healing

Topics: Aged; Carboxymethylcellulose Sodium; Humans; Leg Ulcer; Male; Wound Healing; Wounds and Injuries

To estimate the clinical effectiveness and cost effectiveness of using a sodium carboxymethylcellulose dressing (CMC [Aquacel]) and four super absorbent dressings (DryMax Extra[DM], Flivasorb [F], Kerramax [K] and sachet S [S]) in the treatment of highly exuding chronic venous leg ulcers (VLUs) in the UK, from the perspective of the National Health Service (NHS).. A decision model was constructed depicting the patient pathways and associated management of a cohort of 439 patients with highly exuding chronic VLUs of;;: 3 months of age. The model was based on the case records of a cohort of matched patients from The Health Improvement Network (THIN)database (a nationally representative database of patients registered with general practitioners (GPs) in the UK) who were treated with one of the five dressings. The model estimated the costs and outcomes of patient management over 6 months and the relative cost-effectiveness of using each dressing.. Patients' mean age was 73.1 years, and 46% were female. Between 39% and 56% ofVLUs healed by 6 months. CMC-treated wounds that remained unhealed increased in size by 43% over the study period, whereas unhealed wounds treated with the other dressings decreased in size by a mean 34%. Consequently, CMC was excluded from the cost-effectiveness analysis. The 6-monthly NHS cost of managing a VLU with S was £3700 per patient, which was 15-28% lower than the cost of managing patients with the other three super absorbents. Additionally, use of S improved patients' health status to a greater extent than the other three super absorbents, since S-treated patients accrued 0.3-3% more QALYs. Starting treatment with S was the preferred strategy followed by DM, K and Fin that order.. Within the limitations of the data set,S affords the NHS a cost-effective treatment for managing highly exuding chronic VLUs of ≥3 months of age, compared with DM, F, K and CMC.

Topics: Aged; Bandages; Carboxymethylcellulose Sodium; Chronic Disease; Cohort Studies; Cost-Benefit Analysis; Decision Making; Decision Support Techniques; Female; General Practice; Humans; Leg Ulcer; Male; Models, Economic; Models, Organizational; Practice Patterns, Physicians'; State Medicine; Treatment Outcome; United Kingdom; Varicose Ulcer; Wound Healing

Topics: Bandages; Carboxymethylcellulose Sodium; Female; Humans; Leg Ulcer; Male; Models, Economic; Practice Patterns, Physicians'; Varicose Ulcer

Topics: Bandages; Carboxymethylcellulose Sodium; Female; Humans; Leg Ulcer; Male; Models, Economic; Practice Patterns, Physicians'; Varicose Ulcer

Silver-based dressings have been used extensively in wound management in recent years, but data on their antimicrobial activity in the clinical setting are limited. In order to explore their effects on chronic leg ulcer flora, 14 ulcers were cultured after at least 3 weeks treatment with Aquacel Ag(®) or Acticoat(®). Phenotypic and genetic silver resistance were investigated in a total of 56 isolates. Silver-based dressings had a limited effect on primary wound pathogens, which were present in 79% of the cultures before, and 71% after, treatment. One silver-resistant Enterobacter cloacae strain was identified (silver nitrate minimal inhibitory concentration (MIC) > 512 mg/l, positive for silE, silS and silP). Further studies in vitro showed that inducible silver-resistance was more frequent in Enterobacteriaceae with cephalosporin-resistance and that silver nitrate had mainly a bacteriostatic effect on Staphylococcus aureus. Monitoring of silver resistance should be considered in areas where silver is used extensively.

Topics: Anti-Bacterial Agents; Bandages; Carboxymethylcellulose Sodium; Cephalosporin Resistance; Chronic Disease; Drug Carriers; Drug Resistance, Multiple, Bacterial; Enterobacter cloacae; Genes, Bacterial; Humans; Klebsiella pneumoniae; Leg Ulcer; Microbial Sensitivity Tests; Polyesters; Polyethylenes; Pseudomonas aeruginosa; Sequence Analysis, DNA; Silver Nitrate; Staphylococcus aureus

Topics: Aged; Bandages, Hydrocolloid; Carboxymethylcellulose Sodium; Dermatitis, Allergic Contact; Female; Humans; Leg Ulcer; Occlusive Dressings; Organic Chemicals; Patch Tests

To assess the cost effectiveness of using carboxymethylcellulose dressing (CMCD; Aquacel Hydrofiber) compared to gauze in the management of exuding venous leg ulcers in Germany and the USA.. This was a modelling study performed from the perspective of payers (i.e. the sickness funds in Germany and the community sector in the USA).. Clinical outcomes attributable to managing exuding venous leg ulcers were obtained from the published literature in the English language. These data were combined with resource utilisation estimates derived from a panel of clinicians enabling us to construct two decision models depicting the management of venous leg ulcers with CMCD or gauze over 18 weeks in Germany and the USA. The models were used to estimate the cost effectiveness of CMCD compared to gauze in the management of exuding venous leg ulcers in both countries.. Starting treatment with CMCD instead of gauze in both Germany and the USA is expected to heal 30% of ulcers within 18 weeks compared to 13% with gauze (p = 0.003). The healthcare cost of starting treatment with CMCD or gauze in Germany is expected to be Euro2020 and Euro 2654 respectively at 18 weeks. Additionally, the healthcare cost of starting treatment with CMCD or gauze in the USA is expected to be $3797 and $5288 respectively at 18 weeks. Hence, using CMCD instead of gauze is expected to increase the probability of healing within 18 weeks by 130% and reduce healthcare costs by at least 24%. The healthcare cost of managing CMCD-treated patients was less than that of gauze-treated patients in both countries due to decreased nursing and physician costs associated with a lower frequency of CMCD dressing changes compared to gauze dressing changes. If it were assumed that treatment with gauze in both countries heals 30% of ulcers within 18 weeks (i.e. is identical to CMCD), then the expected healthcare cost of using gauze would be reduced by only 3% (from Euro2654 to Euro2562 in Germany and from $5288 to $5148 in the USA).. Within the limitations of our model, starting management of an exuding venous leg ulcer with CMCD instead of gauze is the cost effective strategy in both Germany and the USA. Moreover, the purchase price of a leg ulcer dressing should not be used as an indication of the cost effectiveness of a given method of care.

Topics: Bandages; Carboxymethylcellulose Sodium; Cost-Benefit Analysis; Germany; Humans; Leg Ulcer; Models, Economic; Monte Carlo Method; United States; Varicose Ulcer

Topics: Aged; Allergens; Bandages; Carboxymethylcellulose Sodium; Colloids; Dermatitis, Allergic Contact; Diagnosis, Differential; Female; Humans; Leg Ulcer; Patch Tests; Syndrome; Urticaria

Topics: Bandages; Carboxymethylcellulose Sodium; Humans; Leg Ulcer; Methylcellulose

Topics: Bandages; Carboxymethylcellulose Sodium; Humans; Leg Ulcer; Methylcellulose