New wound dressings: classification, tolerance

ARTICLE

Auteur(s) : An Goossens¹, Marie-Bernadette Cleenewerck²

¹Department of Dermatology, University Hospital, Katholieke Universiteit Leuven, B-3000 Leuven, Belgium
²AMEST, 118, Rue Solférino, F-59000 Lille, France

accepté le 15 Septembre 2009

Wound dressings are local therapeutic agents intended to create an optimal environment for wound healing, with specific properties according to the type and physiologic healing stage of the wounds [1]. The usual evolution consists of 3 phases: the cleansing phase (exsudative phase), the granulation phase (proliferation phase) and the epithelialisation phase (differentiation phase) [2], corresponding to the final stage of the wound. Some of the new dressings have also been proposed for use in the treatment of non-esthetic scars, as well as for preventing the formation of pathological scars (hypertrophic scars or keloïds) [3].

Classification

• – classic simple dressings (impregnated or not with active components);
• – slightly adhesive dressings;
• – semi-permeable films;
• – hydrogels;
• – hydrocolloids;
• – alginates;
• – collagen;
• – films;
• – polyurethane foams (hydrocellulars);
• – polysaccharides (dextranomers);
• – honey;
• – silicones;
• – hydrofibres (carboxymethylcellulose 100%);
• – hyaluronic acid;
• – enzymes;
• – proteases inhibitors;
• – carbon;
• – silver;
• – combined action;
• – tulles, all or not impregnated, etc.

The materials are passive or active.
Table 1 Principal dressings and biomaterials [5, 25]

Wound dressings: desirable properties

• – preservation of a humid environment;
• – creation of a protective mechanical barrier and thermal isolation;
• – formation of a barrier against secondary infections;
• – maintenance of the humid environment;
• – possibility of gaz exchange;
• – absorption of exudate and micro-organisms;
• – promotion of debridement;
• – absence of trauma at the site of the healing tissue.

Moreover, also other characteristics are important:

• – acceptability to the patient;
• – cost/benefit (cost per unit, application time of the dressing, period of treatment);
• – absence of strong toxic, irritant or allergenic potencies.

Intolerance reactions caused by wound dressings

• – irritant reactions, mainly of mechanical origin, due to occlusion or excessive adhesion of the dressing on the wound;
• – immediate-type allergic reactions (contact urticaria), rarely reported however;
• – delayed-type allergic reactions (contact eczema).

Contact allergic reactions, even multiple sensitizations, occur particularly in the topical treatment of (chronic venous) leg ulcers, the prevalence of which is estimated to be between 1.12 and 4.7% among subjects more than 60 years old [6].

Indeed, contact allergy is favored here by different factors:

• – the use, over a long period of time, of molecules that have strongly sensitizing properties;
• – alteration of the skin barrier, favoring the skin penetration of potentially allergenic substances;
• – occlusion, which also increases skin penetration;
• – haemodynamic troubles: local hyper-vascularisation with the afflux of lymphocytes (which play a role in delayed-type hypersensitivity);
• – increase in the number of Langerhans cells, in and around the ulcer.

In view of the widespread usage of wound dressings, contact-allergic reactions are considered rare, even in a leg-ulcer population. However, their frequency is difficult to determine, for several reasons:

• – the history and the clinical picture might suggest allergic contact dermatitis, however, patch testing with the dressing on healthy skin might be false-negative, particularly taking into account the factors mentioned above;
• – dressings are medical devices, the exact qualitative composition of which is not shown on the label nor on the notice, in contrast to cosmetic (!) and topical pharmaceutical products;
• – moreover, when asking the manufacturing companies in the case of an adverse reaction, the complete composition is rarely revealed, which results in an incomplete contact-allergy investigation.

There are only a few studies investigating the allergenic potential of new wound dressings [7]. According to a study by Gallenkemper and co-workers published in 1998 [8], 20 different dressings were tested in 36 patients with chronic venous insufficiency: positive reactions were observed in 78% of them, mainly to active principles and vehicles present in topical pharmaceutical products, of which only 3 (8.3%) concerned propylene glycol as a component in hydrogels (Intrasite^®, Varihesive hydrogel^®, Hydrosorb plus^®). These authors did not observe reactions to hydrocolloids, nor to alginates, nor to polyurethane foams. Other investigations in leg-ulcer patients, such as those by Tavadia et al. [9] and Machet [10], also reported some rare cases of allergic reactions to hydrogels. In a study by Reichert-Pénétrat et al. [8], differents hydrocolloids were patch tested: Comfeel^® 359 times, Duoderm^® 4 times, Comfeel plus^® 1 time, Algoplaque^® 2 times, and Duoderm E^® 3 times. Only the latter produced a positive reaction in a patient who was also allergic to colophonium. In a recent study from Singapore [11], the results of patch tests obtained in 44 subjects suffering from venous ulcers were collected. 27 (61.4%) presented with at least one positive reaction, 2 of which to Duoderm CGF^® and 1 to Intrasite gel; a third subject presented with a positive reaction to Iodosorb^®.

Meanwhile, other literature reviews on the subject [7, 12-15] most often concern isolated cases of contact-allergic reactions to hydrocolloids, materials commercialized in several countries by the same manufacturer, Convatec Ltd, however, under different names, i.e. Duoderm E^® or CGF^®, Varihesive E^®, Granuflex E^® [12-15], as well as Combiderm^® [7]. In most cases modified colophonium derivatives have been identified as the responsible allergens, and in particular Pentalyn^®, a pentaerythritol ester of hydrogenated colophonium, which is not present in, for example, Duoderm^® [15]. It is important to note that these derivatives, the exact nature of which is not known [7], do not always cross-react with colophonium as tested in the baseline (standard) series. Hence, the responsible allergen was not identified in all cases [7, 14] and the skin reactions were then attributed to irritancy or to contact allergy to non-polymerised substances present in the elastomers, such as e.g. polyisobutylene [16]. In 41 patients suffering from leg ulcers, Schliz et al. [17] identified Pentalyn^® and polyisobutylene as responsible allergens in only 2 cases out of 8 with allergic reactions to Varihesive^® or Comfeel plus transparent^® (Coloplast). In a case reported by Grange-Prunier et al. [18], as well as in our own experience, the identification of the causal allergen involved in contact dermatitis from this hydrocolloid, the composition of which is rather vague (elastomer TR1107?, adhesive P115?), was not successful.

In 1999, carboxymethylcellulose was reported as the causal agent in a patient presenting with the contact urticaria syndrome following the use of Comfeel^® to treat a leg ulcer [19]; more recently [20], this compound was also considered the responsible (delayed-type) contact allergen, not only in Comfeel^®, but also in Varihesive E^® and Aquacel^® (the latter in a patient who also reacted to colophonium).

Allergic contact dermatitis from wound dressings does not only occur in older subjects suffering from leg ulcers, but may also appear in other conditions, for example, in an occupational context [21]. Lee and Kim [22] published a case of contact allergy to propylene glycol present in Intrasite^® gel, used to treat a necrotic ulcer in a patient with scleroderma. In 2007 [23], 3 patients were described, among whom a 14-year-old child and a 19-year-old woman, who presented with contact dermatitis following the application of the non-adhesive dressing Adaptic^®, in order to treat surgical wounds. Patch testing identified sorbitan sesquioleate, a non-ionic emulsifier as the causal allergen. Moreover, the same dressing has also caused dermatitis in leg-ulcer patients [20, 24].

Conclusion

Acknowledgements

References

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