Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries.

BACKGROUND: Incontinence-associated dermatitis (IAD) is a specific type of irritant contact dermatitis with different severity levels. An internationally accepted instrument to assess the severity of IAD in adults, with established diagnostic accuracy, agreement and reliability, is needed to support clinical practice and research. OBJECTIVES: To design the Ghent Global IAD Categorization Tool (GLOBIAD) and evaluate its psychometric properties. METHODS: The design was based on expert consultation using a three-round Delphi procedure with 34 experts from 13 countries. The instrument was tested using IAD photographs, which reflected different severity levels, in a sample of 823 healthcare professionals from 30 countries. Measures for diagnostic accuracy (sensitivity and specificity), agreement, interrater reliability (multirater Fleiss kappa) and intrarater reliability (Cohen's kappa) were assessed. RESULTS: The GLOBIAD consists of two categories based on the presence of persistent redness (category 1) and skin loss (category 2), both of which are subdivided based on the presence of clinical signs of infection. The agreement for differentiating between category 1 and category 2 was 0·86 [95% confidence interval (CI) 0·86-0·87], with a sensitivity of 90% and a specificity of 84%. The overall agreement was 0·55 (95% CI 0·55-0·56). The Fleiss kappa for differentiating between category 1 and category 2 was 0·65 (95% CI 0·65-0·65). The overall Fleiss kappa was 0·41 (95% CI 0·41-0·41). The Cohen's kappa for differentiating between category 1 and category 2 was 0·76 (95% CI 0·75-0·77). The overall Cohen's kappa was 0·61 (95% CI 0·59-0·62). CONCLUSIONS: The development of the GLOBIAD is a major step towards a better systematic assessment of IAD in clinical practice and research worldwide. However, further validation is needed.

Prospective observational study of single- or multi-compartment pressure ulcer prevention cushions: PRESCAROH project.

OBJECTIVE: In patients with reduced mobility, specialised pressure-relieving supports (mattresses, beds and cushions) are widely used to reduce or relieve the interface pressure between the skin and support surfaces to prevent incidence of pressure ulcers (PUs). The primary objective of these two observational studies was to assess the incidence of PUs in patients at high risk of PUs, seated in a wheelchair using a single- or multi-compartment air cushion. The level of patient satisfaction with the comfort and the views of the care team that used the air cushions were considered as secondary objectives. METHOD: The PRESCAROH project was two prospective observational studies conducted in patients free of PUs at baseline and at high risk of PUs (Braden score ≤13 or ≤16 for people with spinal cord injury). Patients had to spend more than eight hours a day in a wheelchair and use either a single-compartment air cushion (patient without asymmetry of support) for the first study or a multi-compartment air cushion (patient with asymmetry of support) for the second study. The primary end point was the percentage of patients in whom a PU (sacrum and/or ischium) developed over a 35-day period. The analysis was performed on the full-analysis set (FAS) of patients included with at least a second assessment. RESULTS: We recruited 152 patients, 78 seated on a single-compartment air cushion (SiCAC group) and 74 on a multi-compartment air cushion (MuCAC group), in the two independent studies. All patients were included in the FAS (n=152). Most patients had spinal cord injuries. The average time spent sitting was 10.2 (standard deviation (SD): 2.3) hours a day in the SiCAC group and 9.1 (SD: 1.9) hours a day in the MuCAC group. In the SiCAC group, 6.4% (5/78) of patients dropped out of the study (one patient because of pulmonary infection and four patients for cushion installation problems). In the MuCAC group, 8.1% (6/74) of patients dropped out of the study (three patients because of adverse events not related to cushions, two for onset of PU, one for cushion-related problem). Over the study period of 35 days, 2.6% (2/78) [95% confidence interval (CI): 0.3-9.0%] of patients in the SiCAC group and 4.0% (3/74) [95%CI: 0.8-11.4%] in the MuCAC group developed a PU. CONCLUSION: These two observational studies showed that in patients at high risk of PUs and seated for more than eight hours a day in a wheelchair, the use of a single-compartment or multi-compartment air cushion with telescopic cells was associated with a low incidence of PUs.

Quality of life in patients with leg ulcers: results from CHALLENGE, a double-blind randomised controlled trial.

OBJECTIVE: We recently showed the superiority of a matrix metalloproteinase (MMP) modulating dressing (foam impregnated with NOSF, nano-oligosaccharide factor) compared with a lipidocolloid matrix (TLC) control dressing in median wound area reduction (WAR). Here we report the results from the same study assessing the performance and safety of TLC-NOSF in the local management of venous leg ulcers (VLUs) or mixed leg ulcers and determining its impact on the patient's health-related quality of life (HRQoL). METHOD: A superiority randomised double-blind controlled trial was conducted on patients presenting with a non-infected leg ulcer (VLUs or mixed leg ulcers) of predominantly venous origin (ABPI >0.8), with a surface area ranging from 5 to 50cm2 and a duration of 6 to 36 months. Patients were randomly allocated to either the TLC-NOSF matrix foam (UrgoStart) dressing group or to the neutral TLC foam dressing group (UrgoTul Absorb). All received appropriate compression therapy and the wounds were assessed blindly (clinical examination, wound area tracing and photographic record) every 2 weeks for a period of 8 weeks, or until complete closure. A secondary endpoint, described here, was the patient's HRQoL, documented by the patient, through the EuroQol 5D tool (EQ-5D) questionnaire and visual analogue scale (VAS). RESULTS: In total, 187 patients were randomised to either the TLC-NOSF group (n=94) or the control dressing group (n=93). The two groups were well balanced at baseline with regard to wound and patient characteristics. In the HRQoL questionnaire (EQ-5D), the pain/discomfort and anxiety/depression dimensions were significantly improved in the TLC-NOSF group versus the control one (pain/discomfort: 1.53±0.53 versus 1.74±0.65; p=0.022, and anxiety/depression: 1.35±0.53 versus 1.54±0.60, p=0.037). The VAS score was better in the test group compared with the control group (72.1±17.5 versus 67.3±18.7, respectively), without reaching significance (p=0.072). Acceptability and tolerance of the two products were similar in both groups. CONCLUSION: The double-blind clinical trial has demonstrated that the TLC-NOSF matrix dressing promotes faster healing of VLUs and mixed leg ulcers and significantly reduces the pain/discomfort and anxiety/depression experienced by the patients. These results suggest that acceleration of VLU healing could improve the HRQoL of the patients and reduced the emotional and social burden of these chronic wounds.

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.

Interest of punch skin grafting for the treatment of painful ulcers.

UNLABELLED: Skin leg ulcers are chronic painful wounds. The treatment of these ulcers is crucial for patients because pain has a significant impact on their daily lives. The analgesic effect of punch skin grafting (PSG) for the treatment of painful ulcers is not well described. The objective of the study is to assess the level of pain in patients with an ulcerated wound and to see if there is an analgesic effect of PSG. PATIENT AND METHODS: A single-center, non-interventional study conducted in hospitalized patients with one or several ulcer(s) of any type and which has been painful for more than six weeks. Pain was assessed before, the day after a PSG and then on the way out of hospital by a questionnaire and a numeric pain rating scale. Permanent pain and pain peaks were identified. RESULTS: Forty-one patients were included (23 men and 18 women) with a mean age of 73±21 years, 36% (n=15) with arterial ulcers, 36% (n=15) with venous ulcers, 12% (n=5) with necrotic angiodermatitis, 12% (n=5) with mixed ulcers and 4% (n=2) with "other ulcers" (due to infection and use of hydroxycarbamide). On day 1 of PSG, patients showed an improvement in terms of permanent pain (77%, n=24/31) and pain peaks (90%, n=37/41) respectively and 90% (n=28/31) and 95% (n=39/41) on the last day at hospital. Reduction in the use of strong opioids was found in 13 patients (81%). CONCLUSION: Punch skin grafting is a simple and validated treatment, which can reduce or eliminate pain related to ulcers. It has an effect on permanent pain and pain peaks. Its efficiency is particularly demonstrated on venous ulcers and mixed ulcers but also initially painful ulcers such as necrotic angiodermatitis or arterial ulcers.

[Interest of punch skin grafting for the treatment of painful ulcers]. / Intérêt de la greffe cutanée en pastilles dans la prise en charge d'ulcères algiques.

INTRODUCTION: Skin leg ulcers are chronic painful wounds. The treatment of these ulcers is crucial for patients because pain has a significant impact on their daily lives. The analgesic effect of punch skin grafting (PSG) for the treatment of painful ulcers is not well described. The objective of the study is to assess the level of pain in patients with an ulcerated wound and to see if there is an analgesic effect of PSG. PATIENT AND METHODS: It was a single-center, non-interventional study conducted in hospitalized patients with one or several ulcer(s) of any type and which has been painful for more than six weeks. Pain was assessed before, the day after a PSG and then on the way out of hospital by a questionnaire and a numeric pain rating scale. Permanent pain and pain peaks were identified. RESULTS: Forty one patients were included (23 men and 18 women) with mean age of 73±21 years, 36% (n=15) with arterial ulcers, 36% (n=15) with venous ulcers, 12% (n=5) with necrotic angiodermatitis, 12% (n=5) with mixed ulcers and 4% (n=2) with "other ulcers" (due to infection and use of Hydroxycarbamide). On day 1 of PSG, patients showed an improvement in terms of permanent pain (77%, n=24/31) and pain peaks (90%, n=37/41) respectively and 90% (n=28/31) and 95% (n=39/41) on the last day at hospital. Reduction in the use of strong opioids was found in 13 patients (81%). CONCLUSION: Punch skin grafting is a simple and validated treatment, which can reduce or eliminate pain related to ulcers. It has an effect on permanent pain and pain peaks. Its efficacy is particularly demonstrated on venous ulcers and mixed ulcers but also initially painful ulcers such as necrotic angiodermatitis or arterial ulcers.

Elevated levels of matrix metalloproteinases and chronic wound healing: an updated review of clinical evidence.

OBJECTIVE: In the past 20 years, research and clinical trials on the healing process of chronic wounds have highlighted the key role of the family of enzymes called matrix metalloproteinases (MMPs). If a strong correlation between the course of healing of chronic wounds and the levels of a biological marker can be demonstrated, then it may be possible to: i) identify the best marker threshold to predict the clinical evolution of the pathology; and ii) if causality has been found between the marker and pathology, to improve the healing outcome, to change the marker level. METHOD: The databases Medline and Embase were searched to identify clinical trials pertaining to the assessment of MMPs in chronic wounds with the following keywords 'metalloproteinase' or 'metalloprotease' and 'wound healing'. Clinical trials were considered for inclusion if they enrolled patients with cutaneous chronic wounds and were published in English. More than 50 clinical trials, consensus documents and guidelines were assessed for this review. RESULTS: MMPs play key roles in the wound healing process, and excessive expression and activation of some of these enzymes is seen in chronic cutaneous wounds where healing is delayed. Levels of MMPs are affected by a number of factors, including patient and wound characteristics. CONCLUSION: Levels of MMPs can be used to indicate the prognosis of chronic wounds and protease modulating treatments used to improve healing rates. DECLARATION OF INTEREST: The authors report no conflicts of interest in this work.

Pressure ulcer prevention and healing using alternating pressure mattress at home: the PARESTRY project.

OBJECTIVE: Specialised pressure-relieving supports reduce or relieve the interface pressure between the skin and the support surface. The comparative effectiveness of dynamic support surfaces is debated. The aim of this study is to examine the impact of using an alternating pressure air mattress (APAM) on pressure ulcer (PU) incidence in patients receiving home-based care. A second aim was to determine the level of patient/family satisfaction with comfort and gain the views of the care team that used the APAM. METHOD: The PARESTRY study was a prospective observational study conducted in patients with a high risk of PUs (Braden score <15), discharged to hospital-care at home. The primary prevention groups consisted of patients with no PU at baseline who were in bed for at least 20 hours a day. Patients at baseline with a category 3 or 4 PU or a category 1 or 2 PU in association with poor general health or end-of-life status were included in the secondary prevention group. All patients were laid on an APAM. The primary end point was the % of patients with a worsening skin condition in the pressure area (heel, sacrum, ischium) at day 90 or at the end of the study. The primary analysis was done on the full analysis set (patients included with at least a second assessment), using the last observation carried forward technique to handle missing data, at day 90. A 95% confidence interval was calculated. RESULTS: Analysis was performed on 92 patients (30 in primary prevention and 62 in secondary prevention). The average time spent in bed was 22.7 (SD 2.7) hours a day and 22.6 (SD 2.2) hours in the primary and secondary prevention groups, respectively. At baseline, in the secondary group, 77% of patients had a sacral PU, 63% a heel PU, 8% an ischial tuberosity PU and 45% a PU in another area, a number of patients having multiple PUs. In the primary prevention group, 63% (19/30) of patients dropped out of the study (5 were hospitalised, 9 died, 5 other causes). In the secondary prevention group, 61% (38/62) dropped out (7 were hospitalised, 23 died, 8 others causes). In the primary prevention group, only one patient had worsening skin condition. In the secondary prevention group, 17.7% (11/62: 95% CI: 8.3-27.2) of patients had worsening skin condition. The number of PUs decreased regardless of location. At the end of follow-up, 49% (45/92) of patients had a PU versus 67% (62/92) at baseline CONCLUSION: This work provides data on the incidence of PUs in patients at high risk, who are using APAMs, and, following inpatient hospitalisation, are taken into home health-care centres. The results of the study highlight the importance of continuity of care across transitions between care settings.

Evaluation of two fibrous wound dressings for the management of leg ulcers: results of a European randomised controlled trial (EARTH RCT).

OBJECTIVE: To evaluate the performance (efficacy, safety and acceptability) of a new micro-adherent absorbent dressing (UrgoClean®) compared with a hydrofiber dressing (Aquacel®) in the local management of venous leg ulcers, in the debridement stage. METHOD: A non-inferiority European randomised controlled clinical trial (RCT) was conducted in 37 centres, on patients presenting with venous or predominantly venous, mixed aetiology leg ulcers at their sloughy stage (with more than 70% of the wound bed covered with slough at baseline). Patients were followed over a 6-week period and assessed weekly. The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period. Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound. RESULTS: Altogether, 159 patients were randomised to either UrgoClean (test group; n=83) or Aquacel (control group; n=76) dressings. Regarding the wound healing process predictive factors (wound area, duration, ABPI value, recurrence), at baseline, the two groups were well balanced, for both wound and patient characteristics. Compression therapy was administered to both groups and after a median 42-day treatment period, the percentage of relative reduction of the wound surface area was very similar (-36.9% vs -35.4% in the UrgoClean and control groups, respectively). When considering the secondary criteria at week 6, the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group (-65.3% vs -42,6%; p=0.013). The percentage of debrided wounds was also significantly higher in the test group (52.5% vs 35.1%; p=0.033). CONCLUSION: This 'EARTH' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel. However, UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage. The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available. DECLARATION OF INTEREST: This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo. S. Bohbot and O. Tacca are employees of Laboratoires Urgo. S. Meaume, J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo. Data management and statistical analyses were conducted independently by Vertical (Paris, France).

Neoplastic wounds and degenerescence.

Between 5% and 10% of cancer patients develop malignant wounds. Cancer wounds can occur as a clinical entity, especially over the breast, with the development of painful, spreading cancer invasions of the skin. Marjolin's ulcers develop in open wounds after a long period, and form rare malignancies arising from previously traumatised, chronically inflamed, or scarred skin. Marjolin's ulcer is associated with malignant transformation of chronic ulcers, sinus tracts, and burn scars. Squamous cell carcinoma may be linked to a wide variety of medical and surgical clinical situations, such as chronic ulcers, sinuses, chronic osteomyelitis, radiotherapy, burn scars, chronic pressure ulcers, as well as cystostomy sites, and Fournier's gangrene scars. Melanomas, lymphomas, and other cancers can also be observed. Basal cell carcinoma is more frequently observed in ulcers associated with venous insufficiency. According to some reports, the ulcer should have existed for at least 3 years to evoke a diagnosis of degenerescence as opposed ulcerated tumour. Epidermoid carcinomas represent between 0.21% and 0.34% of cancers that develop over leg ulcers, but large series are still lacking. The current lack of epidemiological data could be rectified by more frequent evocation of the diagnosis and a policy of systematic biopsy of chronically open wounds.

Prognostic factors associated with healing of venous leg ulcers: a multicentre, prospective, cohort study.

BACKGROUND: Some prognostic markers of venous leg ulcer (VLU) healing have been evaluated, mostly in retrospective studies. OBJECTIVES: To identify which clinical characteristics, among those known as possible prognostic factors of VLU healing, and which VLU-associated sociodemographic and psychological factors, are associated with complete healing at week 24 (W24). METHODS: A prospective, multicentre, cohort study was conducted in 22 French dermatology departments between September 2003 and December 2007. The end point was comparison between healed and nonhealed VLUs at W24, for patient clinical and biological characteristics; psychological, cognitive and social assessments; affected leg inclusion characteristics; venous insufficiency treatment and percentage of initial wound area reduction during follow-up. RESULTS: In total, 104 VLUs in 104 patients were included; 94 were analysed. The mean VLU area and duration were 36.8 ± 55.5 cm2 and 24.8 ± 45.7 months, respectively. At W24, 41/94 VLUs were healed. Univariate analysis significantly associated complete healing with superficial venous surgery (P = 0.001), adherence to compression therapy at W4 (P = 0.03) and W24 (P = 0.01), ankle-joint ankylosis (P = 0.01) and mean percentage of VLU area reduction at W4 (P = 0.04). Multivariate analysis retained superficial venous surgery during follow-up [odds ratio (OR) 8.4, 95% confidence interval (CI) 1.9-48.2] and percentage reduction of the VLU area at W4 (OR 1.6, 95% CI 1.0-2.14) as being independently associated with healing. CONCLUSIONS: These results indicate that complete healing of long-standing, large VLUs is independently associated with ablation of the incompetent superficial vein and percentage of wound area reduction after the first 4 weeks of treatment.

Management of chronic wounds with an innovative absorbent wound dressing.

OBJECTIVE: To evaluate the efficacy and tolerability of an innovative absorbent wound dressing (UrgoClean; Laboratoires Urgo) in the local management of venous leg ulcers and pressure ulcers, during the sloughy stage of the healing process. METHOD: A pilot, prospective, non-controlled open-label clinical trial held in 21 investigating centres. Adult patients, presenting with either a venous leg ulcer (VLU) or a category III/IV pressure ulcer (PU) with more than 50% of the surface area covered with sloughy tissue, a duration of less than 24 months, and no clinical signs of infection were included in the study. Patients were followed over a 6-week period with weekly visits, which included a physical examination, wound-area tracings and photographs by the investigating physician. Evaluations by the nursing staff and by the patients were made at each dressing stage. RESULTS: Fifty patients with either a VLU (n=35) or a PU (n=15) were recruited. At baseline, mean wound surface area was 11.9 ± 11.3 cm(2) and 12.5 ± 10.7 cm(2), with a mean duration of 8.3 ± 6.4 months and 2.9 ± 3.0 months in the VLU and PU groups, respectively. Wounds in both groups were covered with more than 70% sloughy tissue, and the peri-lesional skin was considered to be healthy in 19 patients. By 6 weeks, mean wound surface area reduction in the VLU and PU groups was 23.7% and 29.2%, respectively, with full healing in 6 patients. All treated wounds were considered to be debrided by week 3 (<40% slough for all wounds) and the median relative decrease of the sloughy tissue, at week 6, in the VLU and PU groups was 75% and 89%, respectively. Dressing acceptability was documented as being very good for both patients and nursing staff, particularly conformability and ease of use, with no residue left on the wound bed at dressing removal and the dressing also remained in one piece. Seven local adverse events were deemed to be potentially related to the trial dressing. CONCLUSION: The results suggest that the dressing promoted the healing process of chronic wounds, showing itself to be a credible therapeutic alternative for the sloughy stage of the wound-healing process. It also demonstrated good tolerance and acceptability.

Workload and prevalence of open wounds in the community: French Vulnus initiative.

OBJECTIVE: To calculate the prevalence of open cutaneous wounds presented on a routine working day in community settings in metropolitan France, and to estimate the workload associated with the care of these wounds by nurses, GPs and specialists (dermatologists, diabetologists and phlebologists). METHOD: A transversal epidemiological survey was conducted on a randomly selected sample of the above practitioners between June and July 2008. The percentage of patients presenting on a routine working day with open a cutaneous lesion of any origin, location, size and duration was assessed. All local and systemic care performed on the patient during that day because of the wound was also recorded. RESULTS: In total, 475 GPs, 453 specialists and 238 nurses participated (n=1166) and saw a total of 29 663 patients, of whom 3037 presented with one or more cutaneous wound. The overall non-weighted prevalence of patients with a wound was 10.2% (95%CI: 9.9%;10.6%). This prevalence was similar for GPs (6.0%) and for specialists (6.9%), but was higher for nurses (22.0%). Forty-three per cent of all wounds had a duration of over 6 weeks. These chronic wounds were predominantly leg ulcers, diabetic foot ulcers or pressure ulcers, but also included wounds of all aetiologies. For 33% of all patients with wounds, the impact on their health status was serious to severe. The overwhelming majority of wounds (95%) required local care, including in 65% of cases cleansing and debridement. CONCLUSION: Despite its limitations, this initiative, the first of its type in France, strongly suggests that wound care constitutes an important part of routine care given by health professionals in the community, and for a substantial number of these patients, wounds represent a serious morbidity. DECLARATION OF INTEREST: The non-profit organisation 'Association Vivre avec une Plaie' financially supported this study. This association received unrestricted grants from the French Wound Healing Society (SFFPC) and a consortium of private companies (main sponsors: ConvaTec, Genevrier, Hartmann, KCI, Mölnycke, Smith & Nephew, Urgo; minor sponsors: Coloplast, Covidien, HNE) to fund the costs incurred by the methodological process and statistical analysis but had no input into the findings. The National Health Insurance Organisation provided non-financial support to this initiative. J.C. Kerihuel received support for the submitted work from 'Association Vivre avec une Plaie'. S. Meaume, I. Fromantin and L. Téot have no financial relationship with 'Association Vivre avec une Plaie', for either this or any work submitted in the previous 3 years. The authors have no non-financial interests that may be relevant to the submitted work, and their spouses, partners, or children have no financial relationships that may be relevant to the submitted work

Efficacy of a silver lipidocolloid dressing on heavily colonised wounds: a republished RCT.

Nearly all open wounds are contaminated by microorganisms. This generally corresponds to simple bacterial growth, without leading to deleterious effects or compromising the progress of the healing process. In acute wounds, the probability of wound infection increases as the level of contamination does. However, it is more complex for chronic wounds, which are able to contain and tolerate large amounts of bacteria, many times higher than the usual threshold level (>105 bacteria/g of tissue) defining infection in acute wounds,1 without inducing local signs. Nevertheless, many clinical and experimental studies indicate that the probability for chronic wounds to heal properly is limited when the bacterial load exceeds this level of contamination; even when body defences are still able to prevent tissue invasion, bacteria can impair wound healing.

Clinicians' rationale for using a silver dressing: the French OMAg+E observational study.

OBJECTIVE: To describe motivations for using a silicone, silver-releasing dressing and the type of wounds treated with this dressing, and to evaluate its short-term impact on wound characteristics. METHOD: A French, prospective, observational study of adult patients prescribed a soft-silicone, silver releasing dressing (MepilexAg; Molnlycke Health Care) in the community. Each participating physician was asked to include the first two consecutive patients they treated with the silver dressing, reporting patient and wound characteristics, as well as the presence of I 0 local signs compatible with wound infection (abscesses, purulent or copious exudate, erythema, increase in local warmth, pain, oedema,lymphangitis or satellite adenitis, malodour and delayed wound healing). Clinicians were also asked to select from a list their rationale for prescribing the silver dressing for each patient, including treating a wound infection, to stimulate granulation tissue formation, to promote wound healing, to reduce wound exudate, and to decrease wound pain. Local and general treatment were also reported. RESULTS: Overall, 794 patients (58% females), with a mean age of 69.0 ± 15.4 years, were included by 128 general practitioners, 51 dermatologists and 63 vascular specialist. Sixty-seven per cent were venous leg ulcers (VLUs), 26% were acute wounds (post-traumatic, surgical, burn wounds and animal bites) and 6.3%were other chronic wounds (pressure ulcers, diabetic foot ulcers and oncology wounds). On average 3.7 ± 1.5 local signs of infection were present and mean pain intensity (on a visual analogue scale) was 50± 24mm.According to prescribers, infection and healing delay were the primary rationale in 82% of cases,with oral antibiotics started concurrently in 19% of these wounds. Patients were followed-up at a median of 19 days, by which time all wound parameters were documented as significantly improved. Tolerability and efficiency of the silver dressing was considered as 'good'/'very good' in more than 97% of cases. CONCLUSION: While there are some variances with the French reimbursement indication, for the clinicians surveyed in this study, the primary rationale for prescription of a silver dressing was treatment of a possible wound infection. Although this indication might not always be clinically funded, based on wound characteristics, the short-term impact of this prescription in this series was favourable.

Efficacy of two compression systems in the management of VLUs: results of a European RCT.

OBJECTIVE: To evaluate the efficacy, tolerance and acceptability an innovative two-layer system (KTwo; Laboratoires URGO) versus an established four-layer bandage system (Profore; Smith & Nephew) in the local management of venous leg ulcers. METHOD: A non-inferiority European randomised controlled trial, conducted in 37 centres, in three countries (France, U.K. and Germany), on patients presenting with venous leg ulcers (VLUs). Participants were adult, non-immunosuppressed patients who presented with non-infected, non-malignant leg ulcers, predominantly of venous origin (ABPI > 0.8), with a surface area of 2-50 cm2 and duration 1-24 months. Patients were followed-up every 2 weeks for a period of 12 weeks, or until full closure. Visits included a clinical examination, wound area tracings and photographic evidence. The primary endpoint was the percentage of leg ulcers healed after the 12 weeks, with secondary endpoints of relative wound area reduction (RWAR), absolute wound area reduction (AWAR) and the percentage of wounds with RWAR > or = 40%. RESULTS: In total, 187 patients were randomised to either the two-layer bandage (2LB, n=94) or four-layer bandage (4LB; n=93) system. The two groups were comparable,with regard to wound and patient characteristics, at baseline. By week 12, 44% of VLUs in the 2LB group and 39% in the 4LB group had healed (intention-to-treat [ITT] analysis). The per-protocol (PP) analysis showed that complete wound closure was obtained in 48% and 38% of the 2LB and 4LB groups, respectively. A non-inferiority margin within -10% is considered as demonstrating a 95% and 97.5% confidence interval (p = 0.001). The AWAR was 6.6 cm2 in the test and 4.9 cm2 in the control group. The percentage of wounds with a RWAR > OR =40% was 47% and 44% for the 2LB and 4LB systems, respectively. Pain between dressing changes was reported in 27% of the test and 40% of the control group, and the incidence of adverse events was 17% and 25%, respectively. The 2LB compression system was considered to be significantly easier to apply than the 4LB (p = 0.038). CONCLUSION: The 2LB system (KTwo) was not seen to be any less effective than a well-known 4LB system (Profore) in the management of VLUs. Furthermore, the 2LB system was considered to be easier to apply, representing an alternative to the conventional treatment with 4LB currently available. DECLARATION OF INTEREST: This study was sponsored by a grant from Laboratoires URGO, manufacturers of KTwo. S. Bohbot and A. Sauvadet are employees of Laboratoires Urgo. S. Meaume has received monetary compensation as a speaker for Laboratoires Urgo. Data management and statistical analyses were conducted by Vertical (J. C. Kerihuel; Paris, France).

Use of a new, flexible lipidocolloid dressing on acute and chronic wounds: results of a clinical study.

OBJECTIVE: To document the performance (efficacy, tolerability and acceptability) of Urgotul Flex, a new, more flexible version of the lipidocolloid dressing Urgotul, in the management of acute and chronic wounds. Efficacy was defined as the reduction in ulcer surface area after 4 weeks of treatment. METHOD: This open, non-comparative, multicentre clinical trial recruited patients from 11 centres, which included surgical, burns and rehabilitation units and paediatric, geriatric and dermatology wards. Inclusion criteria were non-infected wounds of any aetiology that were <120cm2 in size. Ulcer surface area was assessed by tracing and planimetry. Acceptability parameters were: ease of dressing application; pain at dressing change; dressing adherence to wound bed and bleeding at removal; maceration of surrounding skin; these were all assessed qualitatively. Patients were followed up for a maximum of 4 weeks, or until they healed if this occurred first. Efficacy and tolerability were assessed by the physicians on a weekly basis, and acceptability by the nursing staff at each dressing change. All of the physicians/nurses had previously participated in clinical evaluations of Urgotul using the same outcomes and assessments, and so performed a retrospective assessment of the two dressings. RESULTS: Forty-four patients from 11 investigating centres were included in the study. The mean baseline surface area at was 21cm2 and 6cm2 for the acute and chronic wounds respectively. Twenty wounds (17 acute wounds and three chronic wounds) healed. Of the remainder, the mean surface area reduction was 78% and 42% for the acute and chronic wounds respectively at the end of the 4-week treatment period. Only two local adverse events were reported, but these were not considered to be dressing related. Based on the 345 documented dressing changes, conformability of the new dressing was considered to be superior to that of Urgotul, particularly when used on acute wounds. CONCLUSION: These findings show that the efficacy and tolerability of Urgotul Flex is similar to that reported in previous observational studies on Urgotul. However, results show it is more flexible and thus more conformable, particularly when used on wounds in awkward locations, including paediatric wounds and hand surgery. CONFLICT OF INTEREST: This evaluation was sponsored by Laboratoires URGO, Chenôve, France.

Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial.

OBJECTIVE: Pressure ulcers affect predominantly the elderly and nutritional status is a known risk factor. Guidelines on pressure ulcers provide recommendation on nutritional management. Ornithine alpha-ketoglutarate (OKG) is an adjuvant treatment in undernourished elderly patients or in patients with hypercatabolism states. It is a precursor of different amino-acids which play a role in the process of healing. The objective of the study is to determine the efficacy of OKG on pressure ulcer area reduction after six weeks of treatment. DESIGN: Multi-centre, international, randomized, comparative, double blind, parallel groups, placebo-controlled study. PARTICIPANTS: 160 patients (ITT population) aged over 60 years with a heel pressure ulcer at stage II or III. INTERVENTION: Patients received OKG (n=85) or placebo (n=75) once a day for 6 weeks. MEASUREMENTS: Ulcer area was measured each week, using a tracer. The primary endpoint was the percentage reduction of the surface at the final visit: [(Wound areatn - Wound areat0)/ (Wound areat0)]. RESULTS: At inclusion, ulcer area distribution deviated from normal distribution (median ulcer area OKG 6.6 cm(2), placebo 3.9 cm2, p=0.044, Mann-Whitney test). As healing is strongly related to baseline ulcer area, the abnormal distribution was a major bias. Therefore it was decided to perform the analysis on 2 sub-groups of patients according to the mean ulcer area, i.e. above or below 8 cm2. The mean wound area reduction for baseline area 8 cm2 no between group differences on either parameter was detected. When closure rate is considered, a significant difference in favor of OKG group is observed (- 0.07 cm2/day in the OKG group and - 0.04 cm2/day in the placebo groups respectively p=0.007, Mann-Whitney test). Thirty serious adverse events were reported in 28 patients (15 allocated to OKG and 13 to placebo). None of them was considered treatment related. CONCLUSION: This clinical trial supports a potential benefit of OKG 10g daily in the subgroup of patients with pressure ulcers

[Incidence of undiagnosed skin cancers in a geriatric hospital]. / Fréquence des cancers cutanés non diagnostiqués en hôpital gériatrique.

BACKGROUND: The incidence of non melanoma skin cancers is closely correlated with age. The aim of this prospective study was to evaluate the prevalence of undiagnosed skin cancers among patients hospitalized in rehabilitation and long-term care units in a geriatric hospital. PATIENTS AND METHODS: All the patients, resident in four rehabilitation and long-term care units and for whom no dermatological advice had been given, were systematically examined by a dermatologist. Clinical data included patient age at the time of the study, gender, relevant historical information, skin phototype and description of the cutaneous lesions. Biopsies were performed for all lesions of suspicious appearance. RESULTS: Three hundred and six patients (79.4% women and 20.6% men aged from 55 to 103 years) were included in the study. Among all the patients, 69.3% were hospitalized for more than one year. Skin phototype was clear for 93.5% of the patients. Thirty-two out of 306 patients (10.5%) presented 42 suspicious lesions and these were diagnosed by histological examination as 16 basal-cell carcinomas, seven squamous cell-carcinomas and two in situ melanomas. Skin cancers were localised on the head and neck in 80% of cases. The prevalence of patients with skin cancers was 5.6% in this population. CONCLUSION: The prevalence of skin cancers among patients hospitalized in geriatric hospitals justifies improved training of geriatricians regarding early recognition and dermatological assessment of cutaneous tumours.

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers.

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new two-bandage compression system in the local management of venous or mixed aetiology ulcers predominantly of venous origin. METHOD: This was a prospective non-comparative open label phase III clinical study. Forty-two patients were recruited from 12 centres. Inclusion criteria included ulcers with at least 50% granulation tissue, a surface area of 2-20 cm2, an ulcer duration of 1-24 months, an ankle circumference of less than 28 cm, and no history of deep vein thrombosis in the three months before enrolment. The primary endpoint was reduction in ulcer surface area, and secondary endpoints were the evolution of leg oedema and patient comfort. During the six-week follow-up, patients underwent weekly clinical assessments and their ulcer surface area was measured by planimetry and photography every alternate week. RESULTS: The mean ulcer surface area at inclusion was 7 +/- 6 cm2. The mean surface reduction after six weeks was 58.5%, with 24% of the treated wounds healing in a mean time of 25.9 +/- 9.46 days. The patients considered that the new compression system had a better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the study. Patient concordance with the new system was excellent and 86% of leg ulcers improved or healed after six weeks. Local tolerance was considered very good. CONCLUSION: This new two-bandage compression system is effective and well accepted by patients.