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Biomedical subjects

S Bohbot

Publications and source records attributed to S Bohbot.

17 recordsLinked to original sources

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.

Acute Disease↗

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.

Adolescent↗

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.

Activities of Daily Living↗

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.

Adolescent↗

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.

Adult↗

The importance of pain reduction through dressing selection in routine wound management: the MAPP study.

OBJECTIVE: To discover the incidence of pain in patients with acute or chronic wounds of various causes during dressing removal, and the effect of switching to a non-adherent dressing. METHOD: A total of 656 primary care physicians reported the relevant details of all acute or chronic wounds observed during routine visits throughout the study period. The pain experienced during dressing changes was systematically evaluated. In patients with moderate to severe pain, a more extensive evaluation was performed and they were invited to complete a self-evaluation questionnaire. If the patients were seen at a subsequent visit, a new evaluation was performed. RESULTS: In total 5850 patients were seen: 2914 with acute wounds and 2936 with chronic wounds. During dressing changes, a similar number of patients with acute and chronic wounds reported 'moderate to severe' pain during the medical screening visit (79.9% and 79.7%) and 'very severe' pain in their self-evaluation questionnaire completed at home (47% and 59% respectively). Dressing removal was most painful when there was adherence to the wound bed. Switching to a new, non-adherent dressing reduced pain during dressing changes in 88% of patients with chronic wounds and 95% of patients with acute wounds. CONCLUSION: This study demonstrates that similar problems with patient acceptability arise irrespective of wound aetiology. Pain is a major problem and is most often related to dressing selection. Selecting a suitable, non-adherent dressing improves patient acceptability.

Acute Disease↗

A silver sulphadiazine-impregnated lipidocolloid wound dressing to treat second-degree burns.

OBJECTIVE: To evaluate the efficacy and tolerance of Urgotul SSD dressing (Laboratoires Urgo) in the treatment of second-degree burns. METHOD: This was a national multicentre phase III non-comparative open-label prospective study involving 10 burns units. The 41 subjects were non-immunosuppressed adults with second-degree thermal burn(s), which were clinically non-infected, less than 24 hours old, had a surface area less than 500 cm2 and warranted the local use of silver sulphadiazine. For four weeks, subjects were followed up weekly with a clinical assessment, bacteriological swabs and photographic recording. RESULTS: Of the 41 patients, 24 healed within a mean of 10.8 days and 13 had a skin graft on the study burn within a mean of 11.5 days. There were four premature study withdrawals. The total number of cumulative treatment days was 445, and 298 treatments were performed (including 257 dressing changes). Mean dressing wear time was 1.73 days. None of the subjects acquired a secondary infection. Researchers took 121 bacteriological samples, and wound colonisation with Staphylococcus aureus was found in only one patient. At follow-up nursing staff reported that dressing acceptability was good. CONCLUSION: Use of Urgotul SSD led to a good wound outcome--wounds healed or were grafted.

Adult↗

Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies.

OBJECTIVE: To evaluate the efficacy, tolerance and acceptability of a lipidocolloid dressing, Urgotul (Laboratoires Urgo), in the local treatment of acute and chronic paediatric wounds. METHOD: Two non-comparative multicentre prospective clinical studies were conducted using the same protocol in France and Germany. A total of 100 patients were recruited from 16 centres (11 in France and five in Germany), and followed up for four weeks. Seventy wounds (55 burns and 15 other wounds) from France and 30 from Germany (22 burns and eight other wounds) were evaluated by nursing staff at every dressing change and by the medical investigator on a weekly basis. RESULTS: In the French study population, 86% of the burns (superficial and deep partial-thickness) and 53% of the other wounds healed completely within the four weeks. Figures for the German study population were 100% and 88% respectively. Pain was evaluated using pain scales adapted to the patient's age (objective pain scale, faces scale for pain and a visual analogue scale) at each dressing change. Dressing removal was non-traumatic, inducing very limited pain. Minor local adverse events were reported in four children. CONCLUSION: Urgotul is not only efficacious, but also well-tolerated and accepted by children with acute and chronic wounds. The dressing, therefore, might be an appropriate and highly promising alternative to conventional dressings.

Bandages, Hydrocolloid↗

[Hydrocolloids and lubricating materials in the treatment of acute and chronic wounds].

The authors carry out a study on a dressing which associates hydrocolloids and a lubricating material, Vaseline, used on 28 patients who suffer from acute or chronic wounds having diverse etiologies. The authors evaluate the biological process through which each wound builds scar tissue, its tolerance, efficiency and degree of acceptance with results which are frankly positive. The data in this study for these parameters coincide with those of other research projects which have been carried out in France, Germany and the United Kingdom.

Acute Disease↗

Urgotul: a novel non-adherent lipidocolloid dressing.

Urgotul belongs to a new class of non-adherent dressings: the lipidocolloid dressings. It is composed of an open weave polyester mesh impregnated with hydrocolloid polymers dispersed within petrolatum. The first clinical trial data are presented. Efficacy and safety were evaluated in a multicentre non-comparative trial involving 92 patients treated to healing or up to 4 weeks. Adult outpatients with acute wounds (n = 34), leg ulcers (n = 24), other chronic wounds (n = 14) or with second-degree burns (n = 20) were included. Results showed 32.4% (n = 11) of the acute wounds, 12.5% (n = 3) of the leg ulcers and 14.3% (n = 2) of the other chronic wounds completely healed before 4 weeks. Surface areas decreased on average by 76.4%, 63.5% and 44.2% at study endpoint respectively. For burns, 19 patients healed (95%) within 5-19 days. A total of 771 dressing changes were performed during the course of the study. Dressing application was considered as easy or very easy in 90% or more of the changes and there was no difficulty in removing the dressing in about 95% of the cases. Safety was good with five reports of a transitory local adverse event, probably dressing-related, being observed, two patients (2.2%) prematurely stopped treatment because of moderate periwound erythema. Urgotul is a highly promising new dressing which is currently undergoing further comparative clinical evaluation.

Adult↗

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.

Aged↗

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.

Aged↗