The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings.

OBJECTIVE: A number of randomised controlled trials (RCT) have compared control groups with TLC-NOSF dressings (UrgoStart) on chronic wounds. Our aim was to determine whether the clinical trials' results translate into routine management of such wounds, by pooling the data from real-life observational studies. METHOD: Observational studies, conducted in France and Germany, evaluating current practices in patients suffering from non-selected chronic wounds treated with a TLC-NOSF dressing were identified. Demographic data, baseline description of wounds and description of their evolution during treatment were extracted and combined. We used two main indicators of clinical outcomes to measure the impact of the TLC-NOSF dressing on this population: time to wound closure and time to 50% reduction of the Pressure Ulcer Scale for Healing (PUSH) score. RESULTS: In total, data from 10,220 patients were included, with 7903 leg ulcers (LUs), 1306 diabetic foot ulcers (DFUs) and 1011 pressure ulcers (PUs). The overall closure rate was 30.8 % [95 % confidence interval (CI): 29.9-31.7 %]. While the country, patient age, and number of wounds were identified as independent prognosis factors of healing, the most significant were wound duration and baseline area. The delay in initiating TLC-NOSF dressings treatment was also found to be significant. Overall the average time to complete closure was 112.5 days [95%CI: 105.8-119.3] for LUs, 98.1 days [95 %CI: 88.8-107.5] for DFUs and 119.5 days [95%CI: 94.6-144.3] for PUs. Based on a subgroup analysis of the French cohort, time to closure is substantially shorter for wounds treated with the TLC-NOSF dressing as a first-line intervention compared with those where it has been prescribed as a second-line intervention. CONCLUSION: Compared with available data on time to complete closure of chronic wounds managed by 'standard' care, the data from this pooled data analysis showed healing time is reduced, which is consistent with the results of RCTs on TLC-NOSF. That these data are in agreement with those from the RCTs is testimony to their generalisability and important for routine practice. This indicates that using TLC-NOSF dressings in routine wound management can reduce the healing time of LUs, DFUs and PUs. These data also suggest that the earlier the decision to use this dressing, the shorter the time to closure, whatever the severity and the nature of these chronic wounds.

Quality of care of patients with chronic lymphoedema in Germany.

BACKGROUND: The management of lymphoedema is complex and should be based on guidelines. To date, no data assessing quality of care in lymphoedema in Germany are available. OBJECTIVE: We aimed at evaluating the quality of care of lymphoedema in the metropolitan area of Hamburg using guideline-based indicators. METHODS: Cross-sectional, community-based study including patients with lymphoedema. Assessment included a structured interview, clinical examination and patient-reported outcomes. Quality indicators derived from guidelines by a Delphi consensus were applied. RESULTS: 348 patients (median age 60.5 years) with lymphoedema (66.4%), lipoedema (9.5%) or combined oedema (24.1%) were included. 86.4% performed compression therapy, 85.6% received lymphatic drainage. On average 55.0% of the quality of care criteria were met; 64.8% were satisfied with care. The distribution curve of the health care index was almost normal. Treatment by specialists led to a higher quality of care index. CONCLUSION: Although overall quality of care in lymphoedema is fair, many patients are not treated properly according to guidelines.

Quality-of-care for leg ulcers in the metropolitan area of Hamburg--a community-based study.

BACKGROUND: Diagnosis and therapy of chronic wounds constitute an interdisciplinary challenge and should be oriented on the guideline standards. Although no data on the quality-of-care are available for Germany, it can be concluded from qualitative estimates and expert reports that the majority of patients are not receiving adequate treatment. OBJECTIVES: Evaluation of the quality-of-care for leg ulcers in the metropolitan area of Hamburg by means of newly developed guideline-based indicators. METHODS: Leg ulcer patients of any aetiology were consecutively included. The spectrum of 220 health-care providers ranged from wound clinics, office-based practices, nursing homes to home-care services and doss houses. The survey included a clinical examination and the completion of questionnaires covering quality of life, experiences with treatment and quality of health care. RESULTS: A total of 520 patients with leg ulcers were included. Among these patients, 63% were of venous, 23% of mixed, 2% of vasculitic and 12% of other origin; 78.6% of the patients were treated with moist wound dressings. Pain therapy was performed in 54.1%, compression therapy in 53.5%. Shortcomings were noted in the diagnostic work-up and in concomitant wound care such as physiotherapy. Around 70% displayed marked to profound impairment in quality of life. The quality-of-care index showed that 64% of the indicators were met by the actual care; 61.8% of the patients exhibiting a sufficient quality-of-care, regardless of age, social status, place of abode or insurance status. CONCLUSIONS: Although the majority of patients received adequate therapy, many patients are not being treated properly in accordance with the guidelines.

A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.

OBJECTIVE: This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management. METHOD: Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing. RESULTS: Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related. CONCLUSION: This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.

Effect of a sustained silver-releasing dressing on ulcers with delayed healing: the CONTOP study.

OBJECTIVE: To compare the effect of the sustained silver-releasing foam dressing Contreet Foam (ColoplastA/S) with local best practice (LBP) on delayed healing ulcers using a real-life setting. METHOD: A total of 619 patients with ulcers of varying aetiologies were treated for four weeks with either the silver foam dressing or LBP. RESULTS: Wound area was reduced by 50% with the silver foam and 34% with LBP Less slough and maceration, a faster reduction in exudate level and more positive wound progress was achieved with the silver foam. In addition, exudate handling, ease of use, odour and pain improved. Less time was spent on dressing changes, and mean wear time was longer for the silver foam (3.1 days) than for LBP (2.1 days). All differences were statistically significant (p < 0.05). The silver foam dressing outperformed all of the other dressing categories including moist wound healing products and other silver dressings. CONCLUSION: This large-scale comparative real-life study shows that the silver foam dressing supports faster healing of delayed healing wounds.

Short-stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates.

OBJECTIVE: To compare the performance of two compression systems, (multilayer elastic [Profore], Smith and Nephew) and (short stretch [Comprilan], Beiersdorf), in the treatment of venous leg ulcers in a randomised controlled trial. METHOD: Eighty-nine patients with venous leg ulcers were randomised to receive treatment with Profore (44 patients) or short-stretch (45 patients) compression bandages. Allevyn (Smith and Nephew) was used as the wound contact layer under both systems. RESULTS: Patients treated with Profore healed significantly faster than those treated with short stretch (p = 0.03) and were 2.9 times more likely to heal at any given time during the study period. Younger wounds healed significantly faster than older wounds (p = 0.01). CONCLUSION: Patients treated with Profore healed faster than those treated with short-stretch bandages. In addition, treatment costs are lower with Profore. In this trial the average cost per patient was [symbol: see text] 1345 (short stretch) and [symbol: see text] 587 (Profore).