Background: Over the last two decades, there have been a number of studies in Europe on contact sensitivity in patients with chronic leg ulcerations with a frequency of positive patch test results ranging from 40 to 82.5%. The prevalence of sensitization has not been studied in North America. Furthermore, many of the newer dressings and wound care products in the market have not been studied for contact sensitivity in patients with chronic wounds. Objectives: 1) To determine the prevalence of allergen sensitivity in patients with history of leg ulcers in two North American study centers, 2) to compare our results to the European studies and to the North American Contact Dermatitis Group (NACDG) database and 3) to help delineate a standard battery of allergens for patch testing in North American leg ulcer patients Methods: 54 patients with an active or past leg ulcer were prospectively entered in the study. The patients were patch tested to both the NACDG Standard series, as well as, a comprehensive supplemental series of 48 allergens including wound care medicaments and dressings. Results: 63% of patients were sensitized to at last one allergen. The most common allergens were Balsam of Peru (29.6%), bacitracin (24.1%), fragrance mix (20.4%), wood tar mix (20.4%), propylene glycol (13.5%), neomycin sulfate (13%), benzalkonium chloride (13%), carba mix (11.1%), nickel sulfate (11.1%) and Duoderm CGF (11.1%). Duoderm CGF was the most allergenic dressing in our study group. Conclusion: There is a high incidence of positive patch tests in patients with past or current leg ulcerations. Using a modified leg ulcer series along with the standard NACDG series is very important in evaluating patients with leg ulcers.

Adequate wound bed preparation is essential for healing of leg ulcers, and consists of controlling exudate and edema, decreasing the bacterial burden, promoting healthy granulation tissue, and removing necrotic tissue. Currently, there is no classification system for wound bed preparation that has predictive value. Based on past work and the authors' experience, we have now developed and tested a new classification system that scores the following parameters: healing edges (wound edge effect), presence of eschar, greatest wound depth/granulation tissue, amount of exudate amount, edema, peri-wound dermatitis, peri-wound callus and or fibrosis, and a pink/red wound bed. Each parameter receives a score from 0 (worst score) to 2 (best score), and all the parameter scores are added for a total score. Each wound can have a maximum score of 16 (the best score possible), to a minimum score of 0 (the worst score possible). We used this wound bed score (WBS) system in a study of 177 patients with venous ulcers who had been prospectively treated with and randomized to either conventional therapy (compression alone) or a living bilayered skin construct (BSC). We evaluated serial photographs at baseline to determine whether the results would be predictive of complete wound closure and could validate the WBS. We found that wounds that ultimately achieved full closure had a statistically significant higher WBS than those that did not heal (p = 0.0012). This was also true when separating wounds by treatment modality: standard therapy (p = 0.044) and treatment with a BSC (p = 0.011). When dividing the WBS in the following quartile groups: scores 4-10, 10-12, 12-13, and 13-16, the percentage of healed wounds correlated with the WBS (p = 0.0008). For all wounds, a one unit increase in total WBS resulted on average in a 22.8% increase in odds of healing (OR = 1.228). This WBS seems to have validity in predicting complete wound closure in wounds treated with either standard therapy or advanced modalities, such as BSC. If confirmed and widely adopted in this and other types of wounds, it could be a useful tool in both the clinical and research setting.

In recent years there has been wider acceptance of aggressive surgical debridement as a means to accelerate closure of diabetic foot ulcers. In a clinical trial by Steed et al.1 involving the use of a topically applied growth factor, thorough surgical debridement of surrounding callus, necrotic ulcer bed, and undermined ulcers' edges was associated with greater incidence of healing and effectiveness of the therapeutic agent. However, at present there is no established way to judge the appropriate extent of debridement and its performance. Here we describe a scoring system to assess whether debridement has been performed adequately. Our scoring system consists of the following three categories: debridement of a) callus; b) ulcer's edge undermining; and c) wound bed necrotic tissue. We assigned a score of 0-2 to each of these categories using the following criteria: 0 = debridement needed but not done, 1 = debridement needed and done, and 2 = debridement not needed. These three scores are then added to give a total ranging from 0 to 6, with the highest number being the optimal score. This instrument, the Debridement Performance Index, evaluates both the adequacy of debridement and whether the ulcer has been or is being properly debrided. To initiate the validation of this scoring system and determine its predictive value for wound closure by week 12, we applied it to 143 patients with diabetic foot ulcers who had been treated in a clinical trial involving either standard therapy (n = 65) or the application of a bioengineered skin construct (n = 78). We blindly evaluated sequential digital photographs of each diabetic foot ulcer and applied the Debridement Performance Index score at day 0, before initiation of either treatment. We found that the lower the baseline Debridement Performance Index the lower the incidence of ultimate wound closure by week 12 ( p = 0.0276). Patients with a Debridement Performance Index between 3 and 6 were 2.4 times more likely to heal than those with a score of 0-2. After controlling for treatment, the Debridement Performance Index was found to be an independent predictor of wound closure (odds ratio = 2.4 95% confidence interval = 1.0-5.6). In conclusion, this novel scoring system for debridement performance appears to be very promising as a predictive tool for determining outcome in clinical trials and, most likely, in clinical practice.

In this paper the basic pathogenesis of cholesterol crystal embolization (CCE) is described, its clinical characteristics are presented and diagnosis and therapy are discussed. The main focus will be on the cutaneous manifestations; however, considering that CCE is a systemic illness, findings in other organs will also be highlighted, particularly the commonly involved renal and gastrointestinal systems.

This was a prospective, randomized, controlled clinical trial assessing the safety and efficacy of a living bilayered skin construct (BSC; Organogenesis, Canton, MA) in treating full-thickness surgical excision wounds. We enrolled 31 patients needing excision of a non-melanoma skin cancer. The patients consisted of 18 females and 13 males, with an average age of 67 years (range: 44 to 84 years). Patients were randomized to either receive a single application of BSC or to heal by secondary intention. Endpoints to assess efficacy included time to complete wound closure, intensity and duration of post-operative pain, cosmetic appearance, patient satisfaction, and quality of the healed wound. Endpoints to assess safety included infection at the wound site and rejection of the BSC. Findings indicate that BSC is safe in the post-operative treatment of acute surgical wounds for removal of non-melanoma skin cancer. The data also suggest that BSC may facilitate management by decreasing post-operative pain. It is unclear whether or not BSC decreases healing time of acute wounds or results in a better cosmetic outcome.

Although the study was unable to detect any statistically significant differences in outcome between the study groups, this small pilot study shows preliminary findings which may indicate an increase in the short-term eradication of BCC using a PC-based vehicle as compared to conventional petrolatum-based formulations.

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Optimal clinical effect was associated with complete wound closure. As the clinical effect becomes less than optimal continued clinical persistence of the construct becomes important. This classification system seems to have validity in predicting complete wound closure in wounds treated with a bilayered bioengineered skin construct.