URGO MEDICAL

Urgotul® a novel non-adherent wound dressing

 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 with acute wounds including burns, or chronic wounds were followed up to 4 weeks or until healing.
Non-adherence to the wound bed, the totally atraumatic and therefore painless removal of Urgotul® were noted during this study in association with a good evolution of the healing process.

References

• Edwards J (2002) Urgotul – product focus J of Comm Nurs 16 (4) : 37-40
• Meaume S, Senet P, Dumas R (2002) Urgotul : a novel non-adherent lipido-colloid dressing. (Results of first clinical trial) Br J Nurs 11 (16) (TVN Suppl) : S42-3, S46-50

Use of a topical negative pressure with a lipido-colloid dressing

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

Sixty-six patients (42 acute wounds and 24 chronic wounds) were enrolled 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 lipido-colloid dressing in conjunction with TNP substantially reduced the pain and dressing adherence during 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.

References

• Téot L. Lambert L. Ourabah Z. Bey E. Steenman C. Wierzbecka E. Malikov S. Charles J.-P.,Vives F. Bohbot S. Use of a topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation. Journal of Wound Care. 2006. 15 (8): 355 – 38.

 

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 focusedon 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.

European Paediatric Study

  This clinical study was conducted using the same protocol in France and Germany. The main goals 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 the 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 incorporated in local wound management strategies in paediatric medicine.

 

References

• Letouze A, Robert M /Voinchet V, Alessandrini P, Dumas R / Bohbot S. Intérêt du pansement Urgotul® dans la prise en charge des plaies en milieu pédiatrique. Journal des Plaies et Cicatrisation. 2002. 32 (V) : 144 - 146
• Letouze A, Voinchet V, Hoecht B, Muenter KC, Vives F, Bohbot S. Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies. Journal of Wound Care. 2004. 13 (6) : 221 – 225
• Meyer T, Höcht B. Lachendes oder weinendes Gesicht: Ist schmerzvermeidende Wundversorgung bei Kindern möglich? ZfW Nr. 2004. 5/04 : 222 – 227

 

Urgotul® in the management of skin lesions in Epidermolysis Bullosa

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.

 

 

 

References

• Blanchet-Bardon C, Bohbot S. Urgotul®, dans la prise en charge des lésions cutanées d'épidermolyse bulleuse. Journal des Plaies et Cicatrisations. 2002. 32(V) : 2 - 4
• Blanchet-Bardon C, Bohbot S. Using Urgotul dressing for the management of epidermolysis bullosa skin lesions. Journal of Wound Care. 2005. 10 (14): 4329 -34

 

 Urgotul® in the treatment of venous and mixed leg ulcers

A multicentre, randomised clinical study was conducted to compare the efficacy, tolerance and acceptability of Urgotul® with a classic 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® lipido-colloid dressing presents better paramedical acceptability rated on the basis of several parameters (pain on removal, odour or maceration).

This study showed the better local tolerance and acceptability of the non-adherent wound dressing, Urgotul®, in association to an equivalent efficacy in the management of leg ulcers.
 

References

• Meaume S, Ourabah Z, Cartier H, Granel-Brocard F, Bressieux J.M, Bohbot S. Evaluation of a lipidocolloid wound dressing in the local management of leg ulcers. Journal of Wound Care. 2005. 7 (14):329 ? 34.

 

Comparison of different wound dressings on cultured human fibroblasts

The aim of this fundamental study was to compare the effects of a new non-adhesive lipido-colloid wound dressing, Urgotul®, with five other wound dressings, including impregnated gauzes and some modern wound dressings.
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).

 

References

• Letouze A, Robert M /Voinchet V, Alessandrini P, Dumas R / Bohbot S. Intérêt du pansement Urgotul® dans la prise en charge des plaies en milieu pédiatrique. Journal des Plaies et Cicatrisation. 2002. 32 (V) : 144 - 146
• Letouze A, Voinchet V, Hoecht B, Muenter KC, Vives F, Bohbot S. Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies. Journal of Wound Care. 2004. 13 (6) : 221 – 225
• Meyer T, Höcht B. Lachendes oder weinendes Gesicht: Ist schmerzvermeidende Wundversorgung bei Kindern möglich? ZfW Nr. 2004. 5/04 : 222 – 227

 

Dressing effects on cellular proliferation and assessment of fibroblast’s adherence in vitro (Bioalthernatives study)

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. 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.

 

References

• Bernard F.X. Barrault C. Juchaux F. Laurensou C. Apert L. Stimulation of the prolifiration of human dermal fibroblasts in vitro by a lipidocolloid dressing. Journal of Wound Care. 2005. 5 (14): 215-20

 

MAPP Study (Medecine Ambulatoire Plaies et Pansement) : Wounds and Pain

The MAPP study was a large-scale survey 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® dressings.

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.
 

 

 

 

 

References

• Meaume S. Téot L. Lazareth I. Martini J. Bohbot S. The importance of pain reduction through dressing selection in routine wound management : the MAPP study. Journal of Wound Care. 2004. 13(10) : 409 - 413

 

URGOTUL/ K-Four

An evaluation of a lipido-colloid dressing, Urgotul®, under multi-layer compression therapy.

This clinical evaluation considers the use of Urgotul under K-Four multi-layer compression K-Four 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 reveal 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.
 

References

• Meaume S. Téot L. Lazareth I. Martini J. Bohbot S. The importance of pain reduction through dressing selection in routine wound management : the MAPP study. Journal of Wound Care. 2004. 13(10) : 409 - 413
  

 

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

To evaluate the efficacy, tolerance and easy of use of a lipido-colloid dressing 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 first occurred. 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 execution (reduced use of supplementary gauzes for the secondary dressing) and duration (shorter nursing time), while
improving patient comfort.

 

Reference

• Meaume S., Ourabah Z.,Charru P., Meyer P.,  Perez J., Sauvadet A.,  Bohbot S. Optimizing wound care with a new lipido-colloid dressing (Urgotul® Duo). British Journal of Nursing (Tissue Viability Supplement).  2007. 16 (6): S4–S12

 

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 use of new lipido-colloid dressing 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 not difference in the number of primary dressings in both groups. In term of secondary dressings, the significat 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 to the protocol used in emergencies to cover low-exuding wounds, sutured or not.

 

Reference

• Coudert B., Bohbot S., Fontanel A., Ciennik A., André A. Intérêt économique de l’utilisation des  pansements  Urgotul® et Urgotul®Duo dans la prise en charge des plaies vues en services d’urgences. Le Revue des SAMU. 2007: 69 - 74.
  

 

 

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Urgotul S.Ag/SSD in the treatment of second-degree burns

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 Urgtul®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.

 

 

References

• Carsin H, Wassermann D, Pannier M, Dumas R, Bohbot S. Traitement des brûlures du second degré par le pansement Urgotul®S.Ag. Résultats d’une étude clinique ouverte. Journal des Plaies et Cicatrisations. 2003. 39 (VIII): 13 - 17
• Carsin H, Wassermann D, Pannier M, Dumas R, Bohbot S. A silver sulphadiazine-impregnated lipidocolloid wound dressing to treat second-degree burns. Journal of Wound Care. 2004. 13 (4) : 145 - 148

 

 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.

The main objective of this clinical study was to assess the ability of a new silver releasing lipido-colloid contact layer 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 clinical trial conducted in parallel groups including different hospital Departments was carried out. Among the selection criteria, the association of 3 of the 5 following items was needed: 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”.

 

References

• Lazareth I, Meaume S, Sigal-Grinberg L, Combemale P, Le Guyadec T, Zagnoli A, Perrot J.L, SauvadetA, Bohbot S. The role of a silver releasing lipido-colloid contact layer in venous leg ulcers presenting inflammatory signs suggesting heavy bacterial colonization: results of a randomized controlled study. WOUNDS. 2008. 20 (6): 158-166

 

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

Physician’s notified parameters concerning the UrgoCell® (Cellosorb®) Non-Adhesive* at follow-up visit.  

The aim of this survey was to evaluate the prevalence and the severity of perilesional skin lesions, the prevalence of poor adherence to compression therapy in outpatients affected with leg ulcers requiring compression, along with the possible relationship between these two parameters.
This prospective observational survey was conducted in outpatients seen by their primary care physicians for the treatment of a venous leg ulcer with no contra-indication to compression bandaging. If patients were seen at a follow-up visit at least 3 weeks after inclusion, investigators had to complete a new questionnaire including overall ulcer evolution (from healed to aggravated) with a clinical evaluation and the adherence of the patients to compression therapy was checked. At this time, the physician asked the patient to give its own opinion concerning the evolution of the leg ulcer, the compression therapy details and their feelings about the primary wound dressing properties.
A total of 2842 patients were included, of whom 2532 were re-evaluated at three weeks and 1397 (49%) returned their questionnaire. The results of this evaluation showed  that on a short-term basis, compliance with compression can be substantially improved by simple measures that include  a non-adherent primary dressing.  The non-adhesive dressing UrgoCell (Cellosorb) prescribed in most patient of this survey met the criteria of good acceptability despite the severity of the perilesional skin status. Education of the patients seems to be essential and will contribuate to a better compliance of the compression therapy.

References

• Dereure O, Vin F, Lazareth I, Bohbot S. Compression and peri-ulcer skin in outpatients' venous leg ulcers: results of a French survey. Journal of Wound Care. 2005. 6 (14):265 – 75.
  

Leg ulcers and the UrgoCell Non-adhesive wound dressing

A  non-comparative, prospective multicentre clinical study was conducted to evaluate the efficacy, tolerance and acceptability of the UrgoCell® (Cellosorb®)  Non-Adhesive dressing in the treatment of venous or mixed leg ulcers. Forty three patients (outpatients or patients initially hospitalized then discharged) presenting with venous or mixed leg ulcers were included in 15 investigating centres.
They were followed-up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs.

The results of this study showed that the surface area of the wound (primary endpoint) was reduced by a mean of 38% after 6 weeks of treatment. Good local tolerance was noted during this study. Acceptability was evaluated by the nursing staff each time the dressing was changed . Nursing staff noted that UrgoCell® (Cellosorb®) Non-Adhesive dressing was very easy to use (dressing application and removal) and the patients particularly appreciated their pain-free removal.
These results demonstrated that the local treatment of the venous leg ulcers with UrgoCell® (Cellosorb®) Non-Adhesive foam in conjunction with compression therapy, allowed a good evolution of the healing process. The acceptability and local tolerance of these products support their usefulness in the management of chronic wounds, like venous leg ulcers.

 

References

• Vin F, Sigal-Grinberg M, Ingen-Housz-Oro S, Estève E, Fays S, Sauvadet A, Bohbot S. Ulcères de jambe et nouveau pansement Cellosorb® Non Adhesive : Résultats d’une étude clinique multicentrique. Phlébologie.2005. 58 (1) : 97-103
• Fays S, Schmutz JL, Vin F, Thirion F, Sigal-Grinberg M, Ingen-Housz-Oro S, Estève E, Sauvadet A, Bohbot S. Leg ulcers and the UrgoCell Non-Adhesive wound dressing. British Journal of Nursing. 2005. 14 (11) (TVN Suppl): S20 – 28
  

 

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Efficacy and tolerance of the Cellosorb® Adhesive dressing in the local management of venous or mixed leg ulcers

A non-comparative open label clinical trial was conducted in 15 investigating centers that included Hospital Dermatology, Vascular Medicine Departments and private physicians. The aim of this study was to evaluate the efficacy and the tolerance of the UrgoCell® (Cellosorb®) Adhesive dressing in the local management of venous or mixed ulcers.
50 patients were treated for 6 weeks with the study dressing, and were evaluated weekly (clinical evaluation, planimetric and photographic records).

The results of this clinical trial showed that the UrgoCell® (Cellosorb®) Adhesive was  effective, safe and very well accepted. The compatibility of tested dressing with the use of compression therapy suggests that UrgoCell® (Cellsorb®) Adhesive dressing plays a valuable role in the treatment of exuding venous and mixed leg ulcers.

References

• Maillard H., Celerier P., Fays S., Schmutz J.L., Peyrin E., Chapelon M., Limonier P., Sauvadet A., Bohbot S. Efficacité et tolérance du pansement Cellosorb Adhesive dans la prise en charge locale des ulcères de jambe d’origine veineuse ou mixte. Abstract Dermatologie. 2005. 12 Numero special
  

 

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

 

To evaluate the performance (efficacy and safety) of an absorbent dressing impregnated with silver salts UrgoCell®Silver (Cellosorb®Ag) 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 12cm2 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 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 (Cellosorb®Ag) may therefore be considered as a new generation dressing indicated in the management of venous leg ulcers presenting local signs suggesting high bacterial colonization.

 

 

 

 

References

• Benigni J.-P. Lazareth I., Parpex P., Alves M., Vin F., Meaume S., Senet P., Allaert F.-A., Sauvadet A., Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. Journal of Wound Care. 2007. 16 (3): 129 - 32.

 

 

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