Annals of Burns and Fire Disasters - vol. XVII - n. 3 - September 2004
TREATMENT OF CUTANEOUS BURNS WITH BURNSHIELD (HYDROGEL) AND A SEMI-PERMEABLE ADHESIVE FILM
Osti E., Osti F.
Emergency Department, San Donà di Piave, Venice, ASL 10 Veneto, Italy
SUMMARY. The objective of this study was to estimate the effectiveness of the association of a transparent adhesive film possessing selective permeability with a hydrogel (Burnshield). This association was used in burn patients in order to reduce skin maceration, improve medication, control pain more effectively, and reduce the incidence of late complications (hypertrophic scars). The external part of the film is impermeable to fluid and micro-organisms but allows transpiration of water vapour from the cutis. The permeability to water vapour of a semi-permeable film in contact with liquids is measured in g/m2/24 h/37 °C and is defined as the moisture vapour transmission rate (MVTR). In our study we used a film with an MVTR equal to 1600. Over a period of about two years, we used this type of therapy in the first-aid treatment of 48 burn patients, four of whom were lost during therapy and four during the follow-up. The most frequent complication, which occurred at various stages during medication, was skin maceration (15 patients out of 44, i.e. 34%). Other complications we recorded during therapy were: infections in two patients (4.5%), vertigo in one patient (2.2%), and abundant fibrin production in one patient (2.2%). In some of the patients we found associated diseases and/or conditions: hepatic cirrhosis, one case; diabetes, one case; epilepsy, one case; pregnancy, one case (33rd week). Four patients were sent to the burns unit, respectively three with second-degree burns in the hand and one patient with second-degree burns in the abdomen and thigh with 12% total body surface area burned. In the re-epithelialization phase we recorded complications in eight patients - seven with residual inflammation (17.5%), and one with hypertrophic scars (2.5%). During the follow-up we recorded late complications in two patients out of 40 (5%). Same Plast Gel® gel was used in eight patients, of whom six out of seven with residual inflammation resolved their clinical picture, while in one patient, in spite of therapy, the residual inflammation evolved into hypertrophic scarring. Treatment with Same Plast Gel® in the two late patients with lesions reduced both thickness and extent, with minimal aesthetic and functional damage. The average follow-up period in all patients was 28.4 months (range, 14-35 months).
The results of studies by Jandera and Arturson suggest that the cooling effect in the treatment of burns, well known as an emergency therapeutic measure, should not be seen merely as cooling but also as a form of topical hydration of the lesion, apart from its systemic effect.1-3 Excess hydration produces maceration of the skin, which can lead to greater exposure to infection in the burn zone. In previous studies we turned our attention to the problem of pain and the complications represented by hypertrophic scars, obtaining encouraging results as regards both problems, and in this study we seek to confirm them, using a combination of Burnshield and a semi-permeable adhesive film (SAF).4,5 Lately, in addition to these problems, we have turned our attention to the question of the practical use of this medication and to the complication of skin maceration in the lesion zone.5 We have attempted to resolve both problems by using SAF. Patients with residual inflammation or hypertrophic scars during follow-up received therapy Same Plast Gel® for a variable period.
The study was conducted from February 2001 to December 2002 in the Department of Emergency Medicine, San Donà di Piave Hospital, Venice. Forty-four patients received this therapy for skin burns of varied nature and variable degree (first to third) in a number of regions of the body. The mean percentage of burned skin in the 44 patients was 4% (range, 1-18%). In children under 15 years of age we used the Lund and Browder table to calculate the percentage of total body surface area (TBSA) burned, and the “rule of nine” in adults.6,7 Twenty-six patients were male and 18 were female (mean age, 33 yr; range, 1-76 yr). Forty-three patients were Caucasian and one was black. Twelve out of the 44 patients (27.3%) had suffered their burns at work; the other 32 cases were domestic accidents.
Table I specifies the causes of the burns and the number of patients. Table II shows the degree of the burn and the number of patients. Table III presents the percentage of skin burned and the number of patients. Table IV gives the location of the burn and the number of patients.
Associated diseases (diabetes, hepatic cirrhosis, epilepsy) conditioned the burn and its prognosis in various ways, but not the condition of pregnancy in the 33rd week. The follow-up consisted of checks every 3 months; four patients left the study at various times during treatment in the burns centre for specialized surgical care (skin graft).
All the burn patients were treated with Burnshield and SAF at their first medication. In some patients this therapy continued for several medications for various causes or considerations. Successive medications and medications complicated by skin maceration continued with conventional medication (cotton gauze, hyaluronic acid, etc.). The patients were medicated until re-epithelialization every 24-48 h, depending on the degree and extent of the burn. Hydrogel (Burnshield) contains water (96%), Melaleuca alternifolia (an essential oil from the tea-tree) (1.03%), and an emulsifying agent with a pH of 5.5-7; the dressing is an inert polyurethane foam. Table V lists of the number of applications of Burnshield and the number of patients.
SAF is made up of biocompatible polyurethane 30 mm thick, which allows good gaseous exchange and the evaporation of water vapour (1600 MVTR), thus limiting maceration. The film is impermeable to bacteria and owing to its elevated elasticity and impermeability is suitable for all parts of the body, thus contributing to good daily hygienic practice without the risk of moistening of the wound. The total number of medications was 321, with a total average of 7.3 per patient (range, 1-15 medications). All the patients received their first medication with Burnshield and SAF, and this type of medication was applied altogether 128 times, with an average of 3 per patient (range, 1-15). Conventional medications (cotton gauze, hyaluronic acid, Vaseline gauze, etc.) were applied 193 times, with an average of 4.3 per patient (range, 1-15). In 15 patients (34%) who at different times during medication presented skin maceration the application of SAF and hydrogel was suspended in the macerated zone and the patients received conventional medication until re-epithelialization. One patient with hypertrophic scars in the hand was sent during the first days of therapy to the referring burns centre for treatment and was lost from the follow-up. Eight patients who during follow-up presented zones of residual inflammation or hypertrophic scars received therapy with Same Plast Gel® three times per day for a mean period of 94.4 days (range, 31-365 days).
We will briefly list here the reasons why Burnshield was used first and in successive medications. In the first medication the aim was to achieve the cooling effect that prevents deepening of the lesion, immediately stops pain, and produces local hydration.2 The second medication was performed in order to achieve effective and long-lasting pain control.4 In successive medications, the purpose was to reduce the temperature in the lesion zone (i.e. to lower metabolism), to reduce the growth stimulus of granulation tissue (deep lesions), and consequently to reduce the possibility of scar sequelae. The hypothesis behind these affirmations is reported in clinical experiences and studies.2-4 It should be borne in mind that skin temperature in zones covered by Burnshield is 3 °C lower than in untreated areas.2-4
Overall, the mean time period for the passing of pain after the application of hydrogel was 2.3 min (range, 1-5 min). Antibiotic therapy was used in two patients (4.5%) for infection in the burn zone. We recorded one case of vertigo (2.2%) 4-5 h after the application of Burnshield, an adverse reaction to hydrogel that resolved spontaneously and has already been mentioned in the literature.8 We recorded complications such as skin maceration in 15 patients (34%). One patient (2.2%) with second/third-degree burns in the thorax (10% TBSA) caused by acid was subjected seven days after therapy commenced to fibrinectomy because of abundant fibrin production. One patient with second/third degree flame burns in the thorax and upper and lower limbs (15% TBSA) received two applications of silver nitrate at a distance of two days following the appearance of excessive granulation tissue in the thorax 49 days after initiation of therapy. Another patient with second-degree hand burns caused by a firecracker explosion (1% TBSA) was sent to the burns centre after the appearance of hypertrophic and retractile scars six days after commencement of therapy. Four patients were transferred for continuation of treatment in the burns centre - three with hand lesions and one with lesions in the abdomen and the thigh. The first three of these patients presented second- and third-degree burns, with a percentage of burned skin ranging from 1 to 2%, while the fourth had second-degree burns in 12% TBSA.
Of the 44 patients, three were admitted to the paediatric unit after initial first-aid therapy. These three were respectively a 1-yr-old child with first/second degree burns in the face and upper and lower limbs (6% TBSA), a 2-yr-old child with second-third degree burns in the thorax and lower limb (15% TBSA), and a 2-yr-old child with first/second degree burns in the abdomen and thigh (12% TBSA).
All the patients admitted, including those discharged from the paediatric unit, were followed in the first-aid out-patient department until re-epithelialization and throughout the follow-up.
Burn-associated diseases variously conditioned the patients’ subsequent evolution. The hepatic patient suffering from cirrhosis with second/third-degree burns (6% TBSA) in the lower limbs showed an insufficient capacity for repair of the damage, with a re-epithelialization period of 60 days. The diabetic patient with second-degree deep burns in the lower limbs (5% TBSA) showed repair of the damage after 33 days. In the epileptic patient the basic disease was the cause of the gravity of the lesions, because during a seizure the patient’s hand remained in contact with a heater for an unspecified period of time, causing second/third degree burns (2% TBSA). This last patient, six days after beginning therapy, was sent to the burns centre for continuation of treatment. The pregnant patient (33rd week) with first/second-degree hand burns (1% TBSA) had no problems repairing the damage.
The mean re-epithelialization time of all the patients in the study was 17 days (range, 4-60 days). At the moment of re-epithelialization we recorded hypertrophic scars in one patient (2.5%) and zones of residual inflammation in seven patients (17.5%). Forty patients entered the follow-up study, and eight patients (20%) with complications were treated with Same Plast Gel®. In one patient with residual inflammation the lesion evolved into hypertrophic scarring in spite of the therapy with Same Plast Gel®. The mean duration of administration of Same Plast Gel® was 94.4 days (range, 31-365 days). The mean follow-up time in all patients was 28.4 months (range, 14-35 months). We observed late complications (hypertrophic scars) in two patients (5%) and dyschromic lesions in six patients (15%).
In an adult, three seconds’ contact with water at 60 °C is sufficient to cause a third-degree burn, and an increase of 8 °C induces the same lesion in one second. A burn must be considered an evolutionary lesion, and in this sense we have found experimentally that in the wound zone there is a rapid and considerable increase in intradermic temperature, and that within three minutes of removal of the cause of the burn there is a rapid reduction in intradermic temperature to below 40 °C. However, post-burn structural and functional alterations last for some hours, and are caused by the inflammatory reactions due to the liberation of chemical mediators, haematic perfusion, and electrolytic exchanges. An experimental study has indicated that within the first hour post-burn there is maximum tissue swelling and that in the wound zone the coefficient of capillary filtration increases by approximately 100%; microvascular permeability increases and peripheral resistance to the haematic flow is considerably reduced, indicating marked vasodilatation.1 The same study, on the basis of the results achieved, attributes the formation of oedema after thermal lesion to various factors, the most important of which would appear to be focal vasodilatation, with an increase in filtration pressure, an increase of in extravascular osmotic activity in the damaged tissue, an increase in microvascular permeability, and alterations in the cellular membrane. This physiopathological phase with its specific clinical manifestations lasts approximately 8 h, which we can define as the “critical phase” in order to differentiate it from the subsequent clinical course (post-critical phase) and the phase of clinical sequelae (chronic phase).1 One possible way to diminish the incidence of post-burn hypertrophic scars could be to reduce the period of re-epithelialization or to lower the temperature in the lesion zone, in order to reduce stimulation of granulation tissue.2 It is to be hoped that studies can be conducted to investigate these hypotheses, particularly as regards the period of re-epithelialization and the use of new materials. The lowering of the temperature in the lesion zone has already been described in the literature2 but remains to be confirmed by wider clinical studies.
The literature reports an incidence of post-burn hypertrophic scars in 45-70% of cases.9 In our study the percentage of patients with hypertrophic lesions was decidedly low (5% of cases), probably because of the effectiveness of the repeated applications of hydrogel according to the second hypothesis underlying the rationale of this study, i.e. reduction of the temperature in the lesion zone by the use of Burnshield. We would stress that it is an essential task of first aid in severely burned patients to provide primary care (hydration, analgesia, medication of the burn, etc.) and tests (chest X-ray, bronchoscopy, etc.) and, once the patient is stabilized, to organize transfer for the continuation of treatment in a burns centre.10
In our study, the personnel who used a semi-permeable adhesive film and Burnshield for medication pronounced a positive judgment regarding its facility of application. The patients’ judgment was also positive, as also that reported in the literature, because thanks to this medication they were able to attend more efficiently to their personal hygiene.11 We recorded a considerable reduction in cases of skin maceration during therapy and good pain control. With regard to late complications (hypertrophic scars) we confirm the positive data of our previous research5 and we can say that such late complications were considerably fewer in percentage than those reported in the literature.9,12-15
RESUME. Les Auteurs de cette étude se sont proposés d’évaluer l’efficacité de l’association d’une pellicule transparente adhésive possédant une perméabilité sélective avec un hydrogel (Burnshield). Cette association a été employée dans des patients brûlés pour réduire la macération de la peau, améliorer la médication, contrôler la douleur plus efficacement et réduire l’incidence des complications tardives (cicatrices hypertrophiques). La surface externe de la pellicule est imperméable aux liquides et aux microorganismes mais permet la transpiration de la vapeur d’eau de la peau. La perméabilité à la vapeur d’eau d’une pellicule semiperméable en contact avec des liquides est mesurée en g/m2/24 h/37 °C et définie comme le taux de transmission de la vapeur de l’humidité (sigle anglais, MVTR). Les Auteurs ont employé une pellicule avec un MVTR de 1600. Pendant une période d’environ deux ans ils ont usé ce type de thérapie dans les premiers secours de 48 patients brûlés, dont quatre ont été perdus pendant la thérapie et quatre pendant le suivi. La cause la plus fréquente des complications qui se sont produites à divers moments de la médication était la macération de la peau (15 patients sur 44, c’est-à-dire 34% des cas). Les autres complications observées incluaient: infections (deux patients, 4,5%), vertige (un patient, 2,2%) et une production abondante de fibrine (un patient, 2,2%). Certains patients présentaient des maladies et/ou conditions associées: cirrhose hépatique, un cas; diabète, un cas; épilepsie, un cas; grossesse, un cas (33ème semaine). Quatre patients ont été envoyés à l’unité des brûlures, respectivement trois patients atteints de brûlures de deuxième degré de la main et un patient avec des brûlures de deuxième degré dans l’abdomen et la cuisse, avec un pourcentage de peau brûlée de 12% de la surface corporelle totale. Pendant la phase de la réépithélialisation, des complications se sont vérifiées chez huit patients - dont sept avec une inflammation (17,5%) et un avec des cicatrices hypertrophiques (2,5%). Pendant le suivi, les Auteurs ont registré des complications tardives chez deux patients sur 40 (5%). Le Same Plast Gel® employé chez huit patients, dont six sur sept atteints d’une inflammation résiduelle, ont obtenu la résolution de leur situation clinique, tandis que la condition d’inflammation résiduelle s’est évolue chez un patient vers une cicatrisation hypertrophique malgré la thérapie. Le traitement avec le Same Plast Gel® chez les deux patients avec des lésions tardives a réduit soit l’épaisseur soit l’extension, avec des séquelles esthétiques et fonctionnelles minimales. Le temps moyen de suivi pour tous les patients était de 28,4 mois (variation, 14-35 mois).