orabase and Varicose-Ulcer

This study compared wound healing efficacy of two silver dressings, AQUACEL(®) Ag and Urgotul(®) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®) Ag to Urgotul(®) Silver. Patients (281) were randomised into two groups. The AQUACEL(®) Ag group had 145 patients treated with AQUACEL(®) Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul(®) Silver group had 136 patients treated with Urgotul(®) Silver for 4 weeks followed by Urgotul(®) for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®) Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®) Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®) Ag group to the Urgotul(®) Silver group was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®) Ag group had statistically higher percentage of subjects with better wound progression (66·9% versus 51·9%, P = 0·0108). In general, both dressings were effective at promoting healing of venous ulcers.

Topics: Adult; Aged; Aged, 80 and over; Bandages, Hydrocolloid; Carboxymethylcellulose Sodium; Chronic Disease; Drug Carriers; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Silver Compounds; Treatment Outcome; Varicose Ulcer; Wound Healing

There are numerous dressings designed to manage the overabundance of matrix metalloproteinases, while also addressing the excessive bioburden found in chronic wounds. The authors compared the efficacy of 2 such dressings: a sodium carboxymethylcellulose/1.2% ionic silver (CMC), which theoretically reduces bacteria by providing silver ions, versus a bovine native collagen (BDC)/ionic silver dressing, which also delivers silver ions in an aqueous environment. Both dressings theoretically modulate the wound bed; CMC through moist wound care and fibrin ingrowth and BDC through matrix metalloproteinase balancing.. A prospective protocol was undertaken using patients as their own controls. Ten patients with bilateral venous stasis or diabetic foot ulcers were selected. One limb was randomized to treatment by either CMC or BDC, whereas the contralateral wound was treated with the other dressing. Biopsies for quantitative cultures were taken at weeks 1 and 4. Wound area was assessed at the weekly visits.. The BDC wounds started with 1.0 × 10 (±1.2 × 10) bacteria, and the CMC wounds started with 1.4 × 10 (±1.3 × 10) bacteria. Over the 4-week period, the bacteria in the 3-ppm (parts per million) silver-treated wound increased 1.53 × 10, whereas in the 21-ppm silver-treated wound, the bacteria increased 1.42 × 10. The rates of closure for CMC-treated wounds was 0.79 ± 0.735 cm/wk and for BDC-treated wounds was 1.38 ± 1.44 cm/wk. Only 1 wound treated with either dressing exhibited a decrease in bacteria.. Both CMC and BDC silver dressings appeared to have statistically similar efficacy regarding the rate of wound healing and little impact on the actual bioburden in chronic lower-extremity wounds. Interestingly, there was no correlation in the size of the wound and any effect on bioburden. Although the BDC dressing showed a higher absolute rate of wound closure, neither technology demonstrated a statistically significant difference in wound closure rate when corrected for initial wound size.

Topics: Anti-Bacterial Agents; Bandages; Carboxymethylcellulose Sodium; Case-Control Studies; Collagen; Diabetic Foot; Humans; Lower Extremity; Matrix Metalloproteinase Inhibitors; Prospective Studies; Silver; Statistics, Nonparametric; Varicose Ulcer; Wound Healing

The aim of this study was to observe both the clinical signs and symptoms of wounds at risk of infection, that is critically colonised (biofilm infected) and antimicrobial-performance of an ionic silver alginate/carboxymethylcellulose (SACMC) dressing, in comparison with a non silver calcium alginate fibre (AF) dressing, on chronic venous leg and pressure ulcers. Thirty-six patients with venous or pressure ulcers, considered clinically to be critically colonised (biofilm infected), were randomly chosen to receive either an SACMC dressing or a non silver calcium AF dressing. The efficacy of each wound dressing was evaluated over a 4-week period. The primary study endpoints were prevention of infection and progression to wound healing. The SACMC group showed a statistically significant (P = 0.017) improvement to healing as indicated by a reduction in the surface area of the wound, over the 4-week study period, compared with AF controls. In conclusion, the SACMC dressing showed a greater ability to prevent wounds progressing to infection when compared with the AF control dressing. In addition, the results of this study also showed an improvement in wound healing for SACMC when compared with a non silver dressing.

Topics: Adult; Aged; Aged, 80 and over; Alginates; Bandages, Hydrocolloid; Biofilms; Carboxymethylcellulose Sodium; Chi-Square Distribution; Female; Glucuronic Acid; Hexuronic Acids; Humans; Male; Middle Aged; Pressure Ulcer; Prospective Studies; Silver Compounds; Treatment Outcome; Varicose Ulcer; Wound Healing; Wound Infection; Zirconium

To evaluate the patterns of silver release from selected sustained silver-release dressings and the protective role of proteins in wound exudate and wound scale. The bactericidal action of silver in chronic wound therapy is also examined.. Sequential microbiological examination of wound swabs from seven patients with chronic wounds and sampling of wound exudate and wound scale. Silver content was measured using atomic absorption spectrometry. The ability of Contreet Foam to absorb exudate and release silver was studied in punch biopsy wounds in a rodent model.. Silver accumulation in wound exudate correlated well with its viscosity and protein content. Silver bound to wound scale and debris was approximately proportional to the silver ion release from dressings. Bacterial burden was controlled, but not eliminated, following chronic silver therapy.. Silver dressings (Acticoat-7, Actisorb Silver, Contreet Foam, Aquacel Ag and Flamazine) were found to be safe for use in chronic wound therapy. Excess silver ion is bound by wound exudate and wound scale as a protective mechanism. Silver-release dressings are not likely to result in germ-free wounds. Further studies are needed to examine potential silver resistance.

Topics: Aged; Aged, 80 and over; Animals; Anti-Infective Agents, Local; Carboxymethylcellulose Sodium; Chronic Disease; Exudates and Transudates; Female; Humans; Male; Middle Aged; Occlusive Dressings; Rats; Rats, Sprague-Dawley; Silver; Treatment Outcome; Varicose Ulcer; Wound Infection

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.

Topics: Aged; Aged, 80 and over; Ambulatory Care; Bandages; Carboxymethylcellulose Sodium; Colloids; Humans; Male; Middle Aged; Organic Chemicals; Pain; Pain Measurement; Severity of Illness Index; Skin Care; Statistics, Nonparametric; Treatment Outcome; Varicose Ulcer; Wound Healing

To compare Aquacel Ag Advantage/Ag+ Extra (Aquacel Ag+) (Convatec, UK) and Cutimed Sorbact (Sorbact) (Essity, US) dressings indicated for the treatment of patients with venous leg ulcers (VLUs), diabetes foot ulcers (DFUs) and pressure injuries (PIs) for clinical performance and outcomes using real-world evidence in Germany and the US.. This study was a chart audit review of patients who used either Aquacel Ag+ or Sorbact dressings in the 24 months prior to October 2022. Healthcare providers with access to electronic medical records and charts were asked to capture data via patient record forms. The quantitative data were analysed.. Findings in Germany were comparable between Aquacel Ag+ and Sorbact with regards to wound description, management and treatment outcomes, including percent area reduction and wound closure. A difference was that a greater proportion of Sorbact patients required surgery (0% versus 11%; p=0.039). In the US, a greater proportion of wounds were worsening before dressing in the Aquacel Ag+ cohort (49% versus 34%; p=0.010). A multinomial logistic regression yielded the result that patients who received Aquacel Ag+ were 3.53 times more likely to have the wound completely healed (p=0.033).. Both Aquacel Ag+ and Sorbact dressings are widely used in Germany and the US for patients with VLUs, DFUs and PIs. Our study found two important differences: patients who used Aquacel Ag+ were less likely to need further surgery in Germany; and in the US, there were significantly higher odds that wounds would completely heal with Aquacel Ag+ dressings compared to Sorbact.

Topics: Bandages; Carboxymethylcellulose Sodium; Cohort Studies; Diabetic Foot; Humans; Treatment Outcome; Varicose Ulcer; Wound Healing

To assess the effectiveness of a new, next-generation antimicrobial dressing (NGAD; AQUACEL Ag+ EXTRA dressing) in managing wound exudate, infection and biofilm, and facilitating progression toward healing.. Clinicians from the UK and Ireland selected stalled or deteriorating wounds that were considered to be compromised by infection and/or biofilm. Only the primary dressing was replaced by the NGAD, for up to 4 weeks or as deemed clinically appropriate; otherwise, standard protocols of care were used. Evaluation forms captured the baseline and final assessment characteristics of wound status, exudate levels, skin health, wound bed appearance, signs of infection and biofilm, and wound dimensions.. In all, 29 wounds were suitable for inclusion in the final analysis. Following the NGAD evaluation, wound statuses were shifted from stagnant/deteriorating to mainly improved, exudate levels were shifted from moderate/high to moderate/low, and skin health was improved in 20 wounds (69%). Wound bed tissue types were shifted from largely suspected biofilm/sloughy tissue (76%) to largely granulation tissue (53%). All signs of clinical infection were reduced in average frequency, with biofilm suspicion falling from 76% to 45% of the cases. The median management period with the NGAD was 4.5 weeks, after which 26 wounds (90%) became smaller in size and 10 wounds (34%) completely healed.. This real-life clinical evaluation of the NGAD suggests that its successful management of exudate, infection and biofilm is generally accompanied by notable improvements in wound health and size, and in some cases, complete healing.. The authors are all employed by ConvaTec Ltd. but have no other conflict of interest to declare. Dressings were provided to the clinicians free of charge.

Topics: Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Bandages; Biofilms; Carboxymethylcellulose Sodium; Diabetic Foot; Female; Granulation Tissue; Humans; Ireland; Male; Middle Aged; Silver; Treatment Outcome; United Kingdom; Varicose Ulcer; 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

Vacuum-assisted closure (VAC) has made a significant contribution to the treatment of acute and chronic wounds. Microdeformational forces from the VAC device accelerate granulation tissue formation when compared with moist saline dressing changes. We present 2 patients with multiple comorbid conditions and complex venous stasis ulcers that had persistent purulent drainage after conventional treatment modalities. Only after utilizing silver-impregnated VAC therapy (GranuFoam Silver), combining the antimicrobial benefits of silver with the advantages of VAC technology, were the wound beds adequately prepared for substantial split-thickness skin grafts. Based on these cases, the silver-impregnated VAC device may be a useful adjunct in wound bed preparation when standard therapies have failed to clear infected wounds. This may lead to improved healing rates and overall decreased wound burden in these complex patients.

Topics: Aged; Bacterial Infections; Carboxymethylcellulose Sodium; Debridement; Humans; Male; Middle Aged; Recurrence; Silver; Vacuum; Varicose Ulcer; Wound Healing

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

Wound healing in venous leg ulcers is a highly complex, dynamic process that is influenced by a number of factors. The primary task of local therapy is to support this natural healing process. While a number of therapeutic agents are available, in most cases their efficacy has yet to be established in controlled prospective studies in the sense of evidence-based medicine. Thus, the physician is left with the task of drawing up individual therapy plans for each patient according to the state of the wound. Compression bandages or stockings form the mainstay of treatment, generally in combination with moist dressings for chronic wounds.

Topics: Anti-Infective Agents, Local; Bandages; Bandages, Hydrocolloid; Carboxymethylcellulose Sodium; Colloids; Debridement; Evidence-Based Medicine; Humans; Hydrogels; Occlusive Dressings; Postphlebitic Syndrome; Varicose Ulcer; Venous Insufficiency; Wound Healing; Wound Infection

Topics: Aged; Alginates; Bandages; Carboxymethylcellulose Sodium; Female; Humans; Male; Middle Aged; Varicose Ulcer; Wound Healing