URGO MEDICAL

Urgotul® a novel non-adherent lipido-colloid wound dressing

Meaume S. et al., British Journal of Nursing, 2002.

 The first non-controlled, multicentre clinical study which confirmed the efficacy, the good tolerance and acceptability of Urgotul was carried out in France. 92 patients aged 18 or over presenting with acute wounds (including burns), or chronic wounds (leg ulcers, pressure ulcers) were followed up to 4 weeks or until healing.
Non-adherence to the wound bed, the completely atraumatic and therefore painless removal of Urgotul® were noted during this study in association with a good evolution of the healing process.

 

Use of a topical negative pressure with a lipido-colloid dressing results of a clinical evaluation

Teot L. Et al. Journal of Wound Care, 2006.

This was a prospective, multicentre, non-comparative study to evaluate the protection and acceptability of Urgotul® dressing in the local management of acute or chronic wounds recieving topical negative pressure (TNP) therapy.

Sixty-six patients (42 acute wounds and 24 chronic wounds) were included in this study with a follow- up period of 17 days in average. The results showed that the 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 inclusion). 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 considered). Wound area and depth were reduced by 19% and 54% respectively by the end of the follow-up period.

The results of this study showed that the use of a contact layer with TLC in conjunction with TNP substantially reduced the pain and dressing adherence during dressing changes.
It therefore makes the use of this technique more acceptable aiming to optimise the management of wounds that are sometimes considered to be in a therapeutic impasse.

 

 

Effects of a lipido-colloid wound dressing, Urgotul® on extracellular matrix synthesis 

The aim of this study was to investigate the effect of Urgotul dressing on the extracellular matrix synthesis.
Normal Human Dermal Fibroblast (NHDF) were cultivated at 37°C in DMEM supplemented with 10% fetal calf serum to confluency. A piece of dressing or a reference compound (positive control) were applied onto the cell layers for 72 hours. Neosynthesis of total GAGs was measured by [3H]-glucosamine incorporation in GAG fraction and sulphated GAGs by 35S-sulfate incorporation; collagen and fibronectin were quantified using specific ELISA assays; matrix organization was visualized by immunofluorescence according to two protocols, one with permeabilisation of cells before labelling (for the detection at the same time of the proteins in cells and of those already secreted and associated for forming the extracellular matrix) and the other without permeabilisation focused on only the extracellular proteins.
In all these experiments, Urgotul® dressing did not significantly modify the overall viability
of the confluent fibroblast cultures. It stimulated the production/release of soluble (pro)collagen I significantly, moderately stimulated the neosynthesis of glycosaminoglycans. Also, Urgotul® seemed to increase the density and the organization of collagen fibres, especially collagen III and it  could increase the amount and labelling of fibronectin molecules associated to extracellular matrix.

Using a new lipido-colloid dressing in paediatric wounds: results of French and German clinical studies

Letouze A. et al. , Journal of Wound Care, 2004.

This clinical study was conducted in France and Germany. The main objectives were to evaluate the efficacy, tolerance and acceptability of the Urgotul® dressing in the healing process of paediatric wounds of any aetiology. A total of 100 patients were included from 16 centres (70 patients from 11 centres in France and 30 patients from 5 centres in Germany). All patients were followed up for 4 weeks and were evaluated on a weekly basis by the medical investigators (clinical and photographic records) and at every dressing change (every 3 days) by the nursing staff.
The pain parameter was evaluated using pain scales adapted to the patient’s age (Objective Pain Scale, Faces, Visual Analogical Scales) at each dressing change. Dressing removal was non-traumatic, inducing very limited pain. Very well tolerated, Urgotul® was highly appreciated by young patients, and the medical and nursing staff and is now in local wound management in paediatric medicine.

 

 

Urgotul® in the management of skin lesions in Epidermolysis Bullosa

Blanchet Bardon C., Journal of Wound Care, 2006

A prospective, single-centre, clinical study on Urgotul® was conducted on 20 patients, both adults and children, suffering from congenital Epidermolysis Bullosa with particularly painful skin lesions. Every patient was followed up for 4 weeks and at the end of study visit a questionnaire on overall acceptability and quality of life was documented. The results demonstrated the good acceptability of Urgotul® in this population, particularly with regards to the lack of pain during dressing changes. In parallel, this dressing was extremely well tolerated and very efficient. The results of the questionnaire showed that the quality of life of these patients was improved by using Urgotul® and that they would be willing to use this dressing for the treatment of their disease in the future.

 

 

 

 

 

 

Urgotul® in the treatment of venous and mixed leg ulcers

Meaume S. et al. Journal of Wound Care, 2006

A multicentre, randomised controlled trial was conducted to compare the efficacy, tolerance and acceptability of Urgotul® versus a standard hydrocolloid dressing. This study was carried out in 20 French dermatological and vascular medicine wards on 91 patients. All patients were divided into two parallel groups with an 8-week follow-up period and were evaluated on a weekly basis.

The results showed that the baseline characteristics of the patients and the wounds were well balanced in the 2 groups. A total of 497 evaluations and 1082 dressing changes were documented. The efficacy of the tested dressings, rated on the basis of the wound surface area, reduction was equivalent in both groups. Analysis of local tolerance revealed a significantly higher number of local adverse events in the control group. Urgotul® dressing presented a better paramedical acceptability rated on the basis of several parameters (pain on removal, odour or maceration).

This study showed a better local tolerance and acceptability of the non-adherent wound dressing, Urgotul®, as well as a comparable efficacy in the management of leg ulcers.

 

 

Comparison of different wound dressings on cultured human fibroblasts and collagen lattices

Viennet C. Journal of Wound Care, 2003.

The aim of this fundamental study was to compare the effects of Urgotul®, with five other wound dressings, including impregnated gauzes and some modern wound dressingson fibroblast proliferation.
Two in vitro culture systems were used to detect possible cytotoxic effects on human dermal fibroblasts cultures in monolayer (morphology, growth of fibroblasts) and the Bell model of cultured dermis equivalents (cell phenotype with ?-SM actin and F-actin labelling).
Urgotul® and its extract did not show any cytotoxic effects, had no significant effect on cell growth cells in contact with Urgotul® had a bipolar and elongated morphology comparable to that of the controls; Urgotul® did not modify the phenotype of fibroblasts (typical of myofibroblasts).

 

 

Stimulation of the proliferation of human dermal fibroblasts in vitro by a lipido-colloid dressing

Bernard FX. Et al, Journal of Wound Care, 2005.

This study is the second fundamental work carried out in vitro. Its aim was to compare the effects of Urgotul® and other greasy dressings on normal human dermal fibroblasts in vitro. The selected endpoints were cell proliferation, the morphology of the extracellular matrix upon dressing removal, and the structure of the underlying fibroblasts. Among the 5 tested greasy gauzes or/and interfaces, only Urgotul® showed a stimulating effect on the proliferation of fibroblasts by 45%. Two dressings did not modify proliferation and two other had cytostatic effects.

In addition, the lesions of the extracellular matrix upon dressing removal were clearly the lowest with Urgotul® (low adherence to cellular surface and/or to extracellular matrix) and the ultrastructure of the fibroblasts in direct contact with Urgotul® was not significantly modified.

 

 

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

Meaume S. et al. Journal of Wound Care, 2004.

The MAPP study was a large-scale observational study of acute and chronic wound care that aimed to determine the prevalence of painful wounds in outpatients. This survey was based on the largest recruitment sample of healthcare professionals and patients. 5850 patients, 656 doctors and 707 nurses were involved in this study. 2914 acute and 2936 chronic wounds were treated with Urgotul® dressing.

The prevalence of moderate to severe pain during dressing change was similar in acute and chronic wounds : 85% and 92% respectively.

The results of this survey showed that in 82,5% of cases patients suffered little or no anxiety during treatment with Urgotul® and in 98% of cases application was found to be easy or very easy by the medical staff. In conclusion, the use of Urgotul®, a non-adherent wound dressing, significantly improves the acceptability of nursing care.

 

 

 

Evaluation of Urgotul® plus K-Four® compression for venous leg ulcers

Smith J. et al. British Journal of Nursing, 2004.

An evaluation of Urgotul®, under multi-layer compression therapy.

This clinical evaluation considers the use of Urgotul® under K-Four® multi-layer compression in 36 patients in both community and hospital settings. The evaluation was conducted in 8 centres in 2003. The dressing was applied under the compression system and removed when the bandage was re-applied. All the patients were treated for 12 weeks or until healing, whichever was the sooner. The dressing was assessed for a number of criteria, including ease of removal, pain, bleeding and maceration. Reduction of the wound surface area was also noted. The results revealed little pain on dressing change, no adherence to the wound bed and no damage to the surrounding skin. The dressings were left in place for an average of 67 days.
This evaluation suggests that Urgotul® is a suitable alternative to traditional contact layers under multi-layer compression therapy for the treatment of venous leg ulcers, providing a moist environment and non-traumatic, pain free removal.
 

 

 

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

Meaume S. et al. British Journal of Nursing, 2007.

To evaluate the efficacy, tolerance and ease of use of Urgotul®Duo, a non-comparative , multicentre clinical trial was conducted in France. Forty-three patients with acute and chronic wounds were includded in this clinical study in 11 active investigating centres. All patients have been followed-up for 4 weeks or until healing. The efficacy, tolerance and acceptability results for this ‘ready-to-use’  dressing were similar to those obtained for the Urgotul dressing in numerous previous studies and for all types of acute and chronic wounds. This well-tolerated new dressing greatly facilitates care operations in terms of application (reduced use of supplementary gauzes for the secondary dressing) and duration (shorter nursing time), while improving patient comfort.

 

 

 

Economic interest of using Urgotul® and Urgotul®Duo dressings in the local treatment of wounds seen in emergency units.

  This was a national, comparative, multicentre observational survey conducted in 4 emergency units. The goal of this trial was to evaluate the medico-economic impact of the use of Urgotul®Duo dressing versus Urgotul®.

Three hundred and five patients were enrolled in this study and the follow-up period was 4 weeks.All patients were divided into two groups: 166 patients were treated for the first 2 weeks with Urgotul® Duo and the rest of the follow-up period with Urgotul®. In the Urgotul® group the treatment has been inversed.
The results of the study showed that there was no difference in the number of primary dressings in both groups. In term of secondary dressings, the significant difference has been: the use of compresses was more important in use of Urgotul® (2,8 compresses) then with Urgotul® Duo dressing (in average 2,8 and 0,2 compresses used respectively). The acceptability was juged much better in the Urgotul® Duo group in term of ease to use and application time.

This study shows the economic interest of using lipido-colloid dressing Urgotul®Duo in patients treated in emergency units. This trial led to the inclusion of this product in the protocol of emergencies to cover non to low-exuding wounds, sutured or not.

 

 

 

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A silver sulphadiazine impregnated lipido-colloid wound dressing to treat second degree burns

Carsin H. et al. Journal of Wound Care, 2004.

The aim of this French multicentre, non-comparative, prospective study was to evaluate the efficacy and tolerance of Urgotul®SSD dressing in the treatment of second-degree burns. This trial was conducted in 10 burns units in France. 41 hospitalised patients with second-degree burns were included. Each patient was treated with Urgotul® SSD dressing for a maximum of four weeks, with a weekly clinical assessment, bacteriological swabs and photographic recording.

The mean healing time was a 10,8 days for 24 burns and 11,5 days for 13 burns which were skin grafted. The mean dressing wear time was 1,73 days. The results demonstrated the good clinical outcome of burns with Urgotul®SSD and the good tolerance and acceptability of the dressing in the local treatment of second-degree burns at risk of secondary infection.

 

 

 Urgotul®SSD. Bacteriological study of the efficacy of silver sulphadiazine

This study showed that the activity of silver sulphadiazine is completely stable. The various bacterial strains involved in the secondary infection of burns remain sensitive to this substance, irrespective of their sensitivity to other antibiotic families. Silver sulphadiazine is bactericidal for all the tested strains, even in the presence of mechanisms of resistance to antibiotics.
This was confirmed with Urgotul®SSD dressing tested on 117 strains of bacteria. (Pseudomonas auroginosa, MRSA, Staphylococcus aureus sensitive to methicilin, â -haemolytic streptococci (A or B)

 

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The role of a silver releasing lipido-colloid contact layer in venous leg ulcers presenting inflammatory signs suggesting heavy bacterial colonization: results of a randomised controlled study.

Lazareth I. et al. Wounds, 2008.

The main objective of this clinical study was to assess the ability of a new antibacterial contact layer with TLC-Ag to promote the healing process of venous leg ulcers presenting inflammatory signs suggesting a heavy bacteria colonization in comparison to the same wound dressing not impregnated with silver salts. An open-label, prospective, multicentre, Randomised Controlled Trial conducted in parallel groups including different hospital Departments was carried out. Among the selection criteria, 3 out of the 5 following items were required: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema. The patients were followed up to 8 weeks on a weekly basis, including a clinical evaluation (clinical score), planimetric area and photographic record. The silver group received a sequential treatment: 4 weeks with the contact layer impregnated with silver salts followed by 4 weeks with a neutral contact layer. The control group received a 8 weeks continuous treatment with the same neutral contact layer. 102 patients were enrolled in the trial and the 2 groups are well balanced at baseline. Reduction of surface area and Clinical Score (primary objective) were significantly greater in the silver group at the end of the 8-week treatment (ITT analysis). That difference was already significant at week 4. The two therapeutic strategies were well tolerated (occurrence of local adverse events). This controlled trial demonstrates the efficacy and the good tolerance of a silver salts impregnated dressing in the management of leg ulcers wounds presenting signs of “critical colonization”.

 

 

 

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Evaluation of the efficacy and tolerance of the new UrgoCell TLC dressing in the local treatment of venous leg ulcers.

Schmutz J.L. To be published.

The objective of this clinical study was to evaluate the efficacy, tolerance and acceptability of the new soft-adherent foam dressing with TLC, UrgoCell TLC, in the treatment of venous leg ulcers. This clinical study included 45 patients presenting with venous leg ulcers. After 6 weeks treatment, the study revealed a 37.4% reduction in wound surface area, with an excellent tolerance and acceptability. The dressing was deemed to be very easy to apply in 98.6% of cases, easy to remove in 99.6% of cases. Pain was absent on removal and the dressing was very conformable to the wound bed.Overall, 79% of the wounds healed or improved.

 

 

 

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Evaluation of the nano-Oligo Saccharide Factor matrix in the local management of venous leg ulcers : results of a Randomised Controlled Trial

Schmutz JL. Et al. International Wound Journal, 2008.

The objective of this open, multicentre, RCT conducted in France and UK was to compare the efficacy, tolerance and acceptability of the new contact layer with TLC-NOSF (Urgotul Start) versus another MMP-inhibitor dressing, in the local management of venous leg ulcers. A total of 117 patients were included, with no significant difference in the two groups.
After 12 weeks follow-up, the mean wound reduction was 54.4% in the TLC-NOSF group versus 13% in the control group. The document acceptability of Urgotul Start was better than in the control group. In terms of local tolerance, the most striking difference between the two groups was the percentage of reported pain and infection in the control group: this was more than double.

 

Urgocell® Start - Results of an observational study in germany

Schmutz. JL. Et al. Poster presented at Harrogate, 2008.

This observational study study was carried out nationwide in germany between september 2007 and april 2008 in physicians practice (general practioners, surgeons, dermatologists) to demonstrate the efficacy, tolerance and acceptability of UrgoCell® START in a widespread collective of ambulant patients.
A questionnaire to be documented by the patient should give details according to the acceptability and the satisfaction with the dressing.
483 centres included 2052 patients. Noticeable was the high number of patients suffering from diabetes (43,5%). 22,4% of patients were clinically obese.The most frequent type of wound was the venous leg ulcer presented by 59% of patients. The median of duration of the wound was 90 days. The median of wound surface area was 10cm² at inclusion.
A median reduction of 75% to 2cm² at the end of treatment was found. 28,1% of wounds healed. 73,5% of the physicians judged the treatment with UrgoCell® START as “extremely useful”. The wearing comfort of the dressing was assessed as “very comfortable” or “comfortable” by 96% of the patients, 93,5% of patients were “very satisfied” or “satisfied” by the dressing.
UrgoCell® START showed good results in treatment of a high number of patients. The wound healing restarts due to the inhibition of MMP and a very fast and considerable reduction of wound surface area was achieved in most cases.

 

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

Lazareth I. et al. Journal of Wound Care, 2007.

 

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 a prospective, non-comparative clinical study has been conducted in France.

A total of 45 patients presenting with leg ulcers on average 12cm ² in size and 15 months in duration, were included and followed up for 4 weeks by a physician on a weekly basis (clinical, planimetric and photographic assessment).
The results of this trial showed that the wound surface area was reduced by a mean of 35% at the end of the follow-up period, with a significant reduction of the clinical score suggesting critical colonization. 470 dressing removals were documented and confirmed that the trial dressing was well accepted on these wounds which showed healthy perilesional skin in 67% of cases at W4 (compared with 13% at baseline).
This new absorbent dressing impregnated with silver salts UrgoCell®Silver is therefore considered as a new dressing indicated in the management of venous leg ulcers presenting local signs suggesting high bacterial colonization.

 

 

 

 

 

 

 

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Urgosorb® dressing : management of acute and chronic wounds

Stevens J. et al. British Journal of Nursing, 2005.

The aim of this 10-patient prospective case study was to evaluate the use of Urgosorb® in the management of acute and chronic wounds. Patients were followed-up during 6 weeks with weekly evaluations. The assessed parameters were fluid management and integrity of surrounding tissue, ease of removal, patient comfort, effectiveness of odour control.

The results showed that 50% of the wounds did heal during the study period, Dressing removal was considered easy in the majority of cases, and patients experienced none, or only mild discomfort. Levels of exudate were well managed and there were no reports of any adverse events.

 

 

Sequential treatment with alginate-CMC and a hydrophobe polyester mesh in lesions of different aetiology

The aim of study was to assess the benefits of a sequential treatment with respect to the fluid management, where an absorbent alginate/hydrocolloid dressing ,  Urgosorb® is first applied (exudative phases) followed by the application of a contact layer with TLC dressing Urgotul® (granulation phase).

During this study, 27 patients with lesions of different aetiology were included and followed-up during one year. Parameters assessed were efficacy, tolerance, acceptability and use frequency.
 
The results of this clinical study showed that the healing occurred after 72,2 days in chronic wounds, 18,3 days in acute wounds and 9,8 days for burns. No local or systemic topical reactions have been noted during this evaluation  and acceptability was also optimal.

This sequential treatment has been recognised as the treatment of choice by patients and staff. It can be used both in hospital, primary care or in home care.

 

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