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.

A 1-Year Follow-Up of Post-operative Scars After the Use of a 1210-nm Laser-Assisted Skin Healing (LASH) Technology: A Randomized Controlled Trial.

BACKGROUND: Laser therapies are used prophylactically for excessive scar formation. The Laser-Assisted Skin Healing treatment induces a controlled heat stress that promotes tissue regeneration. This comparative trial is the first to evaluate the performance of a new automated 1210-nm laser system, compatible with all Fitzpatrick scale phototypes. METHODS: Forty women undergoing bilateral breast reduction were enrolled in this double-blinded randomized controlled trial. The horizontal sutured incision of one breast was treated with the portable 1210-nm laser while in the operating theatre. The other breast was used as the study control. Objective measurements, subjective clinical assessments and safety evaluation were carried out over 1 year by both clinicians and patients. RESULTS: Six weeks following surgery, better overall appearance and modified OSAS scores were reported for the laser-treated scars when compared to the control group (p = 0.024 and p = 0.079). This supports an early effect of the laser treatment during the inflammatory stage of the healing process. After a post-treatment period of 6 months, there continued to be a strong tendency in favour of the laser treatment based on the subjective scores and corroborated by the objective improvement of the treated scar volume (p = 0.038). At 1 year, the laser-treated scars continued to improve compared to the control ones in terms of volume (p = 0.004), surface (p = 0.017) and roughness (p = 0.002), and these comparatively better results were strengthened with the blind expression of patients' preference for their laser-treated scar (p = 0.025). CONCLUSIONS: This new 1210-nm laser treatment, used as a single session performed immediately after surgery, provides significant objective and subjective improvements in scar appearance. These data can be useful when preparing patients to undergo their surgical procedure. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Clinical evaluation of a dressing with poly absorbent fibres and a silver matrix for managing chronic wounds at risk of infection: a non comparative trial.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new silver poly absorbent dressing (UrgoCleanAg) in the local management of exudative chronic wounds at risk of infection, with inflammatory signs suggesting heavy bacterial load. METHOD: This prospective, multicentre, non-comparative clinical trial was conducted in French hospital wards (dermatology and vascular medicine) or specialised private-practice physicians. Patients were considered at high-risk of infection when presenting with at least three of five selected inflammatory clinical signs, suggesting a heavy bacterial load (pain between two dressing changes, erythema, oedema, malodorous wound and presence of a heavy exudate). They were treated for a maximum period of four weeks, and followed by the physician on a weekly basis, including a clinical examination, area tracings and photographs. The primary efficacy criterion of the trial was the relative wound surface area reduction at the end of the four weeks of treatment. Acceptability was documented by the nursing staff at each dressing change between the weekly evaluations. RESULTS: We recruited 37 patients with chronic wounds. Wound surface area, mostly covered by sloughy tissue, was reduced by 32.5% at the end of the treatment (median value), while the clinical score (maximum value of 5, based on inflammatory clinical signs) decreased from 4.0 to 2.0. Effective debridement properties were documented (62.5% relative reduction of sloughy tissue at week 4; 58.8% of debrided wounds at week 4) and improvement of the periwound skin status was noted (healthy for 28.6% of the patients at week 4 versus 2.7% at baseline). In addition, the tested wound dressing presented a good safety profile associated to a high level of acceptability, noted by both patients and nursing staff. CONCLUSION: These clinical data support that the tested dressing is a credible therapeutic alternative for the management of chronic wounds at risk of infection with inflammatory signs suggesting heavy bacterial load.

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).

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.

Management of diabetic foot ulcers with a TLC-NOSF wound dressing.

OBJECTIVE: To evaluate the efficacy, tolerance and acceptability of UrgoStart Contact (Laboratoires Urgo), a new wound dressing impregnated with NOSF, as an MMP regulator in the management of neuropathic diabetic foot ulcers. METHOD: A multicentre, pilot, prospective, non-controlled open-label clinical trial. Adult patients with type 1 or 2 diabetes mellitus, who had a grade 1A (Texas classification), uninfected, neuropathic foot ulcer, 1-15cm2 in size and of 1-20 months' duration (mean 6.7 ± 5.2 months) were included in the study. The primary endpoint was the relative reduction of the wound surface area (%) at the end of the study. Secondary endpoints included rate of complete healing, and tolerability and acceptability of the dressing. The wound dressing was changed regularly at the investigator's discretion, in accordance with the wound status and exudate level. Patients were followed up every 2 weeks for a 12-week period. At each visit, patients underwent clinical assessments, and ulcer surface area was measured by planimetry and photographs. RESULTS: Thirty-four diabetic patients with a neuropathic foot ulcer were included but only 33 cases were analysed, as data were completely lost for one patient. At baseline, mean surface area was 2.7±2.4cm2. At the 12-week follow-up, the median surface area reduction was 82.7% (mean reduction 62.7 ± 49.9%) and in 10 of the 33 analysed patients (30%) the wound was healed. Only two of the seven documented local adverse events were deemed to be dressing related. According to the nursing staff, acceptability was considered very satisfactory, particularly in term of conformability and ease of use. CONCLUSION: This pilot study indicates that use of the new UrgoStart Contact dressing, combined with offloading and debridement,may help promote the healing process of the neuropathic diabetic foot ulcers, and was well tolerated and accepted.

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.

Association of autologous punch grafting, TLC-NOSF dressing and multitype compression therapy to rapidly achieve wound closure in hard-to-heal venous leg ulcers.

OBJECTIVE: To document the efficacy of a combined therapeutic strategy in achieving rapid wound healing in patients with long-standing ulcers. MATERIALS AND METHODS: Outpatients with hard-to-heal venous leg ulcers were included in an interventional, prospective, single-arm, mono-centre study and treated with autologous punch grafting, TLC-NOSF dressing and multi-type compression therapy. The primary outcome was the percentage of healed wounds by week 12. Secondary outcomes included time-to-reach wound closure, wound area reduction, treatment acceptability and safety. RESULTS: From November 2018 to October 2019, 42 patients with 51 ulcers were included (23 males, 70.6±40.8 years old, with multiple comorbidities). Despite poor wound healing prognosis at baseline (47% of recurrent ulcers, with a mean duration of 15 months and a mean area of 12.6cm2), wound healing was achieved in 47 ulcers (92%) after a mean period of treatment of 25±13 days. A relative wound area reduction>75% was also reached in three additional ulcers by the last evaluation visit. No adverse event related to the procedure was reported throughout the study period. The associated treatment were very well tolerated and accepted by the patients. CONCLUSIONS: The evaluated procedure induced fast re-epithelisation of the treated ulcers. Based on our experience, this simple and successful reparative strategy may be considered as an interesting option in the treatment of venous leg ulcers of poor prognosis.

Comparison of interface pressures of three compression bandaging systems used on healthy volunteers.

OBJECTIVE: To compare changes in interface pressures of three compression systems (four layer, two layer and short stretch) recorded over seven days in healthy volunteers in different positions: supine, sitting, active standing and working pressure during exercise. METHOD: Twenty-four volunteers were bandaged with one of the three compression systems on both legs. Interface pressures were measured at inclusion (day 0) and on days 1, 3 and 7 using an air sensor system, with the sensor placed in the medial B1 position above the inner ankle. In addition, the volume of the lower legs were also measured on days 0 and 7 using a three-dimensional imaging system. Comfort and tolerability were also assessed. RESULTS: The performance, based on the loss of interface pressure compared with baseline, of the two-layer system was partially better than that of the short-stretch system for maximal working pressure and loss of volume. The two-layer system and short-stretch system had similar results for the supine, sitting and active standing positions. No difference was observed between the two-layer system and the four-layer system for the maximal working pressure. However, the two-layer system compared better than the two other systems for comfort and tolerability: 25% of the patients treated with the four-layer system discontinued the treatment after three days because of pain. CONCLUSION: The two-layer bandage system maintained, over one week, a similar level of sub-bandage pressure similar to a four-layer system and was partially better than short-stretch bandaging. However, the volunteers found the two-layer system more comfortable and tolerable than the other two systems. DECLARATION OF INTEREST: The investigators received an education grant from Urgo for the study. However, Urgo had no influence on the data analysis or interpretation.

Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers.

OBJECTIVE: To evaluate the performance (efficacy and safety) of an absorbent dressing impregnated with silver salts (UrgoCell Silver) in the management of leg ulcers with clinical signs of critical colonisation. METHOD: This was a prospective multicentre non-comparative phase III clinical trial. Patients were assessed weekly for up to four weeks. Assessment included clinical assessment of critical colonisation (severe spontaneous pain between dressing changes, erythema, oedema, malodour and heavy exudate), wound area tracing and photography. Acceptability was documented by the nursing staff when dressings were changed between two weekly evaluations. RESULTS: Forty-five leg ulcers were included. At baseline the mean number of clinical signs of critical colonisation per ulcer was 3.6 +/- 0.7, which decreased to 1.2 +/- 1.2 at the end of the fourth week of follow-up (an average reduction of 2.3 +/- 1.3, p < 0.001). Oedema, malodour, erythema and spontaneous pain disappeared at the fourth week in 80%, 70%, 69% and 65% of the treated ulcers respectively. Compared with baseline, the mean reduction in ulcer area was 35.0 +/- 58.0% (median 33%, p < 0.001) after the four weeks treatment. Granulation tissue covered a mean 77% of the ulcer surface area at four weeks, compared with 41% at baseline. Only three local events were documented: contact dermatitis, a burning sensation and erythema. CONCLUSION: The results suggest that the test dressing had a favourable influence on the wound prognosis, and was well tolerated and accepted in the treatment of venous leg ulcers with clinical signs of critical colonisation.

Optimizing wound care with a new lipido-colloid dressing (Urgotul Duo).

This non-comparative, multicentre clinical trial includes 43 patients whose acute or chronic wounds were treated with a new lipido-colloid dressing, Urgotul Duo, for at most 4 weeks, or until healing first occurred. The efficacy, tolerance and acceptability results obtained from this 'ready-for-use' dressing were similar to those reported for the Urgotul dressing in numerous previous clinical trials, and for all the different types of acute and chronic wounds. This well-tolerated new dressing greatly facilitates care operations in terms of execution (reduced use of supplementary gauzes for the secondary dressing) and duration (shorter nursing time), while improving patient comfort. This dressing is indicated for the local treatment of moderate exudative acute and chronic wounds in the granulation and epidermization phases.

Use of topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation.

OBJECTIVE: To evaluate the protection and acceptability of Urgotul wound dressing in the local management of acute or chronic wounds receiving topical negative pressure (TNP) therapy. METHOD: This was a prospective multicentre non-comparative open-label trial. At each dressing change the investigating physician clinically evaluated and photographed the wound. Planimetric measurement was undertaken and wound depth was assessed at the start and end of the treatment. Follow-up was undertaken until deemed clinically unnecessary by the investigator. RESULTS: Sixty-six patients were included (42 acute wounds and 24 chronic wounds) and followed up for an average of 17 days. Dressing changes were deemed entirely painless in 52% of cases (compared with 18% at baseline) and pain between two consecutive dressing changes was absent in 66% of cases (34% at baseline). Removal of the TNP-interface dressing combination was considered'very easy' or 'easy' in 94% of cases and adherence to the wound was recorded as 'absent' in 88%. On average, the dressings were changed every 3.8 +/- 1.1 days (all wounds were considered), and wound area and depth were reduced by 19% and 54% respectively by the end of the follow-up period. CONCLUSION: Use of the interface dressing in combination with TNP substantially reduced the pain caused by dressing changes. It therefore makes more acceptable the use of this technique, which aims to optimise the management of wounds that are sometimes considered to be in a therapeutic impasse.

Using Urgotul dressing for the management of epidermolysis bullosa skin lesions.

OBJECTIVE: To evaluate the acceptability, tolerance and efficacy of Urgotul wound dressing in the management of epidermolysis bullosa (EB) skin lesions. METHOD: This was an open-label uncontrolled clinical trial involving 20 patients (I I adults and nine children) with EB simplex or dystrophic EB. Patients were selected from the register of EB patients at the investigating centre and included if they presented with at least one skin lesion requiring management with a non-adherent wound dressing. Lesions were treated with the study dressing for a maximum of four weeks. All dressing changes, wound parameters, pain and effect on quality of life were recorded. RESULTS: All patients completed the trial. Nineteen out of 20 wounds healed within 8.7 +/- 8.5 days. Overall, 11 patients (55%) considered that their quality of life had improved following use of the dressing, which was also reported to be pain free and 'very easy' or 'easy' to remove at most dressing changes. Nineteen out of 20 patients stated that they would use the study dressing to manage their lesions in future. CONCLUSION: This study confirmed the very good acceptability and efficacy of Urgotul in the treatment of skin lesions in patients with EB.

Compression and peri-ulcer skin in outpatients' venous leg ulcers: results of a French survey.

OBJECTIVE: To evaluate concordance with compression therapy in ambulatory patients with venous leg ulcers. METHOD: This was a prospective observational survey conducted in general practice. Consecutive patients with venous leg ulcers about to receive a non-adherent primary dressing and with no contraindication to compression bandaging were selected. At the inclusion visit, size, local aspect of the ulcer and the peri-ulcer skin were scored. Patients were asked about concordance with compression and were given a questionnaire to be completed at home. If patients were seen at a three-week follow-up visit, ulcer and peri-ulcer characteristics and concordance were reassessed. RESULTS: A total of 2842 patients were included, of whom 2532 were re-evaluated at three weeks and 1397 (49%) returned their questionnaire. A compression bandage was already available for 62.9% of these patients, and 62.7% said they used it on a daily basis, 23.3% wore it one or two days per week and 13.7% wore it irregularly or never. There was a statistically significant correlation between concordance with compression and ulcer and peri-ulcer skin severity scores (p < 0.001 and p = 0.042 respectively). At the follow-up visit, concordance with compression therapy improved (80.1% were wearing it regularly). Ulcer, peri-ulcer skin severity scores and ulcer size were significantly lower (p < 0.001) when concordance with compression therapy was good. However, 65.6% of patients considered applying compression very difficult; 45% considered it very unaesthetic and 23% judge wearing it to be very painful, while 9% thought it may worsen their ulcer. CONCLUSION: On a short-term basis, concordance with compression can be substantially improved by simple measures with a clear favourable consequence on both ulcer status and peri-ulcer skin aspect when a non-adherent primary dressing is used. However, the acceptability of compression to patients is poor, and continuous effort is required to convince them of its importance.

Preventing the occurrence of pressure ulceration in hospitalised elderly patients.

OBJECTIVE: To determine which factors contribute to the development of pressure ulcers and to evaluate the role of topical agents in preventing their occurrence. METHOD: An observational, prospective survey covered 36 care of the elderly wards and involved 1121 patients at high or very high risk of pressure ulceration. The patients, of whom 667 (59.6%) received a gentle application of a topical agent to at-risk areas, were followed up for eight weeks. RESULTS: Of the patients, 15.7% developed a pressure ulcer. The use of a corpitolinol 60-based topical agent (Sanyrène/Corpitol) significantly reduced the incidence of pelvic pressure ulcers (p=0.04) when used with recognised prevention strategies. This was identified by undertaking a logistic regression analysis. The resulting odds ratio of 0.61 indicates that the intervention helped to reduce the number of pressure ulcers by 40%. CONCLUSION: The results of this observational study can provide a useful guide to the design of further randomised controlled trials.

Evaluation of a lipidocolloid wound dressing in the local management of leg ulcers.

OBJECTIVE: To evaluate the efficacy, tolerance and acceptability of Urgotul and DuoDERM E dressings in the local management of venous or mixed-aetiology leg ulcers. METHOD: 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. RESULTS: 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). CONCLUSION: 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.

Leg ulcers and the Urgocell Non-Adhesive wound dressing.

The objectives of this clinical trial were to evaluate the efficacy and tolerance of the Urgocell Non-Adhesive (NA) dressing in the local management of venous or mixed leg ulcers. The study was a non-comparative, prospective, multicentre (15 centres) phase III, clinical trial. The studied population was composed of non-immunodepressed adults presenting a venous or mixed leg ulcer, uninfected, non-cancerous, present for less than 18 months. Patients were followed up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs. Evaluation by nursing staff and patients was performed at each dressing changed. Forty-three patients were included, presenting a leg ulcer with a mean surface area of 10.7 cm2. The surface area was reduced by a mean of 38% after 6 weeks of treatment. Four local adverse events were deemed to be related to the tested treatment and acceptability was noted very good for patients and nursing staff. The Urgocell NA dressing, combined with compression therapy, promoted the healing of the chronic wounds under study. The good tolerance and acceptability of the tested dressing were greatly appreciated.

Healing properties of calcium alginate dressings.

In a prospective, randomised, controlled trial of 92 patients with full-thickness pressure ulcers, the efficacy of an alginate wound dressing was compared to that of an established local treatment with dextranomer paste. During treatment, a minimal 40% reduction in wound area was obtained in 74% of the patients in the alginate group and in 42% of those in the dextranomer group. The median time taken to achieve this goal was four weeks with alginate and more than eight weeks in the control group. Mean surface area reduction per week was 2.39 cm2 (sd 3.54) and 0.27 cm2 (sd 3.21) in the alginate and dextranomer groups respectively (p = 0.0001). This difference was still highly significant when the sub-groups of almost completely healed subjects at the end of the study were considered. This striking healing efficacy of an alginate dressing suggests it possesses pharmacological properties which require further investigation.

Healing properties of calcium alginate dressings.

In a prospective, randomised, controlled trial of 92 patients with full-thickness pressure ulcers, the efficacy of an alginate wound dressing was compared to that of an established local treatment with dextranomer paste. During treatment, a minimal 40% reduction in wound area was obtained in 74% of the patients in the alginate group and in 42% of those in the dextranomer group. The median time taken to achieve this goal was four weeks with alginate and more than eight weeks in the control group. Mean surface area reduction per week was 2.39cm2 (sd 3.54) and 0.27cm2 (sd 3.21) in the alginate and dextranomer groups respectively (p=0.0001). This difference was still highly significant when the sub-groups of almost completely healed subjects at the end of the study were considered. This striking healing efficacy of an alginate dressing suggests it possesses pharmacological properties which require further investigation.