Epidermolysis bullosa (EB) is a heterogeneous group of rare, inherited diseases characterized by fragility and blistering of skin and mucous membranes. In severe forms, this may involve a wide range of complications, including gastrointestinal, ophthalmological, respiratory, and genitourinary problems and disabling musculoskeletal deformities.1 The United States National Epidermolysis Bullosa Registry2 estimates an incidence of 50 cases of the disease per 1 000 000 live births; 92% of these cases are the simplex variance, 5% dystrophic, 1% junctional, and 2% unclassified, each type determined by specific gene mutations.2 Clinically, individuals with EB have fragile skin and are susceptible to painful and recurrent blistering, often following minimal friction, trauma, or everyday activities; there also is a high probability of infection and scarring.3
Currently, no effective treatment is available for patients affected by EB; wound care is the main challenge to severe EB. The goal of EB clinicians is to choose a dressing that will prevent blistering by meticulously protecting skin, limiting friction, decreasing pain, and promoting healing.4
The American Academy of Dermatology5 has published a list of advanced dressings that potentially can be used for the local management of EB lesions; these include nonadherent dressings such as lipidocolloid, silicone, foam, and hydrogel dressings. In choosing nonadherent primary dressings to be applied on the wound bed, clinicians should consider the size and location of the lesions, frequency of dressing changes, cost, and the economic status of the patient.6 In addition, it is important to keep in mind that few of these dressings have been studied in clinical trials to evaluate their benefits; most information relies on data from case reports or case series.
Since 2008, to our knowledge, Urgotul lipidocolloid dressing (Urgo Medical, Fort Worth, TX) has been used in the largest clinical trial regarding its EB indication.7 This nonocclusive dressing is made of nonwoven polyester mesh impregnated with hydrocolloid particles dispersed in a petroleum jelly matrix. Numerous clinical studies have demostrated the benefits of using Urgotul in the treatment of chronic wounds8,9 and acute wounds including burns and wounds in a pediatric population,10 as well as in clinical data widely supported by European surveys.11 A prospective clinical study was performed to evaluate the acceptability, tolerance, and efficacy of this lipidocolloid dressing in the treatment EB skin lesions.
An open, prospective, noncomparative clinical trial was performed in the Dermatology Department of the Saint Louis University Hospital (Paris, France) among 20 outpatients presenting with EB skin lesions to evaluate patient acceptability and tolerance of the Urgotul dressing. Acceptability was assessed on a 3- or 4-stage scale for each evaluated parameter, and tolerance was based upon documentation of local adverse events by the investigator if/when they occurred. Urgotul wound dressing was initiated at the inclusion visit and continued in each recruited patient until the lesion healed or for a maximum of 4 weeks. Healing was defined as dressing no longer needed and no exudate. If more than 1 lesion was present on the body, the investigator selected which lesion would be included in the study. Care was performed by the family or nursing staff and documented in a patient book at each dressing change. Dressing changes were performed on a daily basis, owing more to the habits of care in this pathology than to the recommendations of use of the dressing (usually changed every 2 to 3 days). Analyses were descriptive because this was a noncomparative trial performed on an intention-to-treat basis for both primary and secondary endpoints and considered all patients included in the trial.
Population and pathology data at baseline. The study population comprised 11 adults (5 women, 6 men; mean age 29 [range 18–55] years) and 9 children (5 boys, 4 girls; mean age 6 [range 1–4] years). None of the 20 patients was lost to follow-up. EB disease was dystrophic in 13 patients and simple in the 7 others. The treated lesions (eg, see Figure 1 and Figure 2) had a mean duration of 9 (range 1–45) days and were located on all parts of the body (upper limb, inferior, hand, thorax); the majority were located on a lower limb (11/20 lesions). The mean large axis of the lesions was 4 cm (range 1–10 cm), and the mean small axis was 2.5 cm (range 0.7–6 cm).
A total of 172 dressing changes were documented in the course of 214 cumulative treatment days.
Acceptability. Urgotul dressing was noted as very easy or easy to apply (see Figure 3) in 94% of the encounters, and removal of the dressing was considered very easy or easy in 98% of the encounters. In 150 (87%) of dressing changes, the dressing was removed dry (without previous humidification), and in 22 (13%), dressings were removed using saline or during the bath.
Pain was reported as totally absent in 135 of the 148 (90%) dressing changes documented for this factor, and as a result of no wound adherence in 137 out of 147 (93%) of the dressing removals. No premedication had to be used in >90% of the dressing changes; when needed, paracetamol (tablet or syrup) was prescribed.
No bleeding occurred at removal of the dressing in 88% of the dressing changes.
Tolerance. For 1 patient during 2 dressing changes, a transient sensation of itching was reported at dressing removal, for a few minutes and noted as minimal; the trial treatment was continued and the lesion healed.
Efficacy. At the final visit (week 4) (eg, see Figure 4 and Figure 5), 19 lesions (95%) had healed in a mean healing time of 8.7 days, and only 1 lesion stagnated in 1 of the children.
When patients (or their parents) were asked to compare Urgotul with their previous dressing (eg, gauze, paraffin, or silicone dressings), 15/20 patients (all 9 children and 6/11 adult patients) reported dressing changes were less painful with Urgotul than with previous dressings. Sixteen (16) patients (all 9 children and 7 adults) reported feeling less apprehension during care with Urgotul. Nineteen (19) patients (or parents) confirm they will accept to be treated again with Urgotul for future blisters/lesions.
A prospective, open, noncontrolled study was performed among 20 patients with congenital EB lesions. This study was the first clinical trial to evaluate Urgotul in this very specific EB indication. This trial demonstrated the acceptability of this dressing in this population, particularly regarding the painless nature of dressing change, as previously noted in a survey12 involving patients presenting with acute and chronic wounds. The benefits/acceptability of the Urgotul dressing appeared highly favorable in this EB population, demonstrating this dressing’s role among the nonadhesive dressings used for wound healing in patients suffering from EB.
Urgo Medical is a proud supporter of the Dystrophic Epidermolysis Bullosa Research Association of America (DEBRA) Foundation.