Osti E., Osti F.

Department of Emergency Medicine, Ospedale Civico, San Donà di Piave, Venice, Italy

SUMMARY. Cutaneous lesions due to burns constitute a major problem. When deep, even if they affect only a small percentage of the cutis, they are slow to heal, become infected, cause persistent pain, and lead to unaesthetic scarring and invalidity. When the burn is severe, it can cause death because of a variety of complications - septicaemia, acute renal insufficiency, respiratory distress syndrome, cardiocirculatory failure, etc. This preliminary study was carried out on burn patients with cutaneous lesions in a percentage of total body surface area that generally does not require hospitalization (> 10% for a child and > 20% for an adult). The analgesic efficiency of the anti-burn hydrogel product Burnshield® was tested and, after the follow-up, we intend to assess its aesthetic and cicatricial effects. Twenty patients received a local application of Burnshield®. Good results were found with regard to the analgesic efficiency of Burnshield®, which was effective almost immediately and persistent. However, with regard to the risk of infection, further research requires to be done. The complication most frequently observed was maceration of the cutis, even if this did not prevent continuation of treatment with the hydrogel.

Introduction

Clinically, the seriousness of a burn is judged on the basis of its extent, depth, and location, the concomitance of other lesions or illnesses, and the patient’s age and general state of health. In small, superficial burns, the patient’s general state is not compromised, while in more extensive burns (over 40% in adults and 20% in children), whether superficial or deep, they cause serious illness and may lead to complications. These include septicaemia and ulceration of the digestive system. Many studies have been conducted using pharmaceutical products for the cutaneous lesions caused by different types of burn, with more or less similar results. The literature indicates that in all cases the use of very low temperatures should be avoided because they can produce a thermal shock and even cause further damage.1-7 A useful guide in burns is the “15 rule”, which recommends cooling within 15 min with sterile water at 15 °C for at least 15 min.5

Burnshield® is a hydrogel dressing that is indicated for use in burns and scalds of all degrees, as confirmed experimentally by the reduction of the temperature in the injured area.8 In our studies we used sterile saline solution at a temperature of 23 °C for 15 min, followed by Burnshield® at the same temperature. The same method was used with subsequent medications, until re-epithelialization of the lesions. It is hoped that a more in-depth clinical study will be able to evaluate the overall efficiency of this anti-burn product.

The device for the clinical study was supplied by TEK.IM s.n.c. The study was conducted in the Department of Emergency Medicine, San Donà di Piave Hospital, Venice, Italy.

Record of cases

In this preliminary study, conducted between July 2000 and January 2001, patients were treated for skin burns and scalds of varying degree (first to third), due to various causes, in different parts of the body. The total body surface area (TBSA) burned varied from 1 to 50% (average, 6.15%). Altogether, twenty patients were treated in the Department of Emergency Medicine (average age, 38.5 yr; range, 1-79 yr). Four patients were male and sixteen female. The burns were first degree in two patients, first/second degree in two, second degree in nine, second/third degree in five, and third degree in two. One diabetic patient with second- and third-degree burns in 50% TBSA was subjected to cooling with saline solution in the emergency department. After Burnshield® had been applied, the patients received support treatment for their burns (abundant hydration and radiological, reanimatory, and routine blood chemistry tests). When stable, they were transferred to the locally responsible burns unit. One patient was excluded from the study because of intolerance to Burnshield®, which manifested itself after the second application of the hydrogel. Eighteen patients were involved in the study, all of whom were treated in the casualty department and dismissed after clinical healing of the lesion.

Table I specifies the chemical and physical agents that caused the burns. Table II presents, with regard to the twenty patients, the age, cause of burn, location, degree, and percentage of body surface area affected.

Method

Hydrogel Melaleuca Alternifolia Burnshield® is a new product indicated for the treatment of cutaneous lesions due to burns. It contains 96% water, 1.03% melaleuca (an essential oil from the tea tree), and an emulsifying agent with a pH of 5.5-7. The dressing is made up of an inert polyurethane foam with an interlocking cellular structure. The different-sized sterile confections come in aluminium packets. The hydrogel smells like turpentine. The effects of this essential oil have long been known.9,10 In this study the packets of hydrogel were stored at room temperature (circa 23°), as also the saline solution used to cool the burned cutis. All the patients received repeated medications with Burnshield® at intervals ranging between 12 h and 2 days, depending on the degree and extent of the burn. The lesions were first cleaned and cooled with saline solution for 15 min or treated surgically if there was necrosis or abundant fibrin. The burned area was then medicated using the hydrogel, with an overlapping area of some 2 mm sealed with a waterproof, transparent film in order to prevent leakage of the gel and to keep the medication in position. In subsequent medications, the injured area was cleaned and the blisters and necrotic areas were surgically eliminated and treated with Burnshield®, as in the acute phase.

Results

All the patients received repeated applications of Burnshield® (total number, 167), with an average number of 9.3 medications each (range, 2-39). The total number of medications was 208 (average, 11.5; range, 2-49). The difference between the total number of medications and that with the hydrogel was 41 dry medications (average, 2.5; range, 1-10) with simple cotton gauze or a Vaseline-coated gauze, performed mainly in the 10 patients presenting lesions complicated by maceration - this did not however require interruption of the treatment. The average time for complete healing (re-epithelialization) was 24.1 days (range, 2-108). The average time, in all cases, before cessation of pain in the burn was 2.2 min (range, 1-5). In no case was it necessary, either during the acute phase or during subsequent treatment, to give or prescribe any analgesic medicine. The result of complete re-epithelialization, as evaluated when the patient was discharged after treatment with Burnshield®, was judged to be good or satisfactory in nearly all cases.

One patient was transferred to the Burns Unit because of the extent and complexity of the injuries. Six types of complications were observed: maceration of healthy cutis surrounding the burn in 10 patients (55.5% of cases); initial infection in two patients (11.1%); intolerance to the hydrogel in one patient (5.5%); allergy to the film in one patient (5.5%); abundant production of fibrin in one patient (5.5%); and excessive scar tissue in two patients (11.1%). Antibiotic therapy was administered in two patients: one of these had applied an unsterilized astringent (rock alum) to the burn, aggravating the initial degree of the burn from second degree to third, while in the other patient (a child aged 1 yr) antibiotic therapy was used as a prophylactic measure in view of the high percentage of damaged cutis (9%), the severe degree of the burn (second/third), and the concomitant presence of a viral infection (chickenpox).

The various complications that appeared at different times during therapy (maceration, initial infection, allergy to the film, abundant production of fibrin, and the presence of excessive scar tissue) caused us to interrupt therapy, but never to suspend it altogether. However, therapy was totally suspended after the second medication in one patient who developed intolerance to Burnshield®. The patient who displayed an allergy to the film after 10 days’ treatment with the hydrogel was treated in the casualty department with parenteral antihistamine- and cortisone-based treatment and continued to receive medications with Burnshield®. The patient who 20 days after starting the therapy presented excessive scar tissue was dabbed with silver nitrate in the following two medications, leading to smoothing and levelling of the lesion. The patient with abdominal lesions who 20 days after starting therapy presented an abundance of fibrin was subjected in the following two treatments to fibrinectomy; also, because of the presence of excessive scar tissue, the patient was dabbed with silver nitrate (four medications), with subsequent re-epithelialization. In this study we do not yet possess sufficient follow-up data to be able to express an opinion on the possible manifestation of keloids, hypertrophic scar disfigurement, or invalidity.

Discussion

Cooling a burned area is an emergency measure that both clinically and experimentally has always shown benefits.9,12-16 Cryotherapy improves tissue reaction against thermal damage. This is demonstrated by the reduction of hyperthermia in the after-burn period, the reduction of inflammation, the exchanges in the microcirculation (less capillary permeability), and the reduction of necrotic and fibrous tissue. There is also a reduction in the release of histamine, prostaglandins, and thromboxin, as well as a reduction of the aerobic metabolism and a drop in the production of lactic acid and metabolic acidosis. Increased epithelial cell growth has also been observed with cryotherapy.2-4,6,17-20 Experimentally, immersion in cold water has significantly reduced pain and burn-induced mortality from 64.5 to 2.58%.14 The optimal temperature for maximum benefit has yet to be determined, and experiments have been conducted with water temperatures ranging from 8 to 30 °C (Pushkar, 15 °C; King, 10-12 °C; Boykin, 8-10 °C; Raghupati, 17 °C; Demling, 15 °C; Ofeigsson, 15-30 °C; and Davies, 25-30 °C). These temperatures refer to the surface temperature of the cooling agent, while the effects of the temperature on the intracutaneous structure have not been evaluated. The temperature of the cooling agent (water or Melaleuca), i.e. around 15 °C, does not appear to damage tissue under the burn, as confirmed by several experimental studies.8,21-23 Jandera’s experimental study8 demonstrated histologically almost complete re-epithelialization 21 days post-burn in water-cooled patients and in patients cases treated with Melaleuca hydrogel. The effectiveness of repeated application of Burnshield® and/or cold water at 15 °C on the burn wound also appears to be confirmed experimentally.8 A single application of the hydrogel has a similar effect to that of repeated applications of water-cooled compresses; however, the cooling effect of this product seems to diminish after about an hour and care must be taken in serious burns in view of the risk of hypothermia.8 For this reason, repeated use needs to be reduced in time compared with cold-water compresses, while continual use is possible when cooling for a long period of time is necessary.8 The mechanism of Melaleuca’s action is unknown, but a heat change action is assumed, as the gel comes in a volume consisting of 96% water.8 In view of the experimental results, it would appear that the optimal water temperature for cooling is 16-18 °C.8 It has also been demonstrated in patients with cutaneous infections due to a variety of bacteria that 5% Melaleuca exerts local antiseptic action and also restricts growth.24,25 In our study, skin burn lesions were first treated with saline solution at room temperature (23 °C) for 15 min, after which Burnshield® at the same temperature was applied. Compared with other methods of treatment for burns, we observed a more immediate and persistently effective effect on pain using the hydrogel.

The average time for healing (re-epithelialization) in our study was comparable with that of others in the literature.8 When we complete the follow-up we will be able to evaluate the aesthetic and cicatricial results. We observed complications with regard to maceration of the cutis in 55.5% of cases. The percentage of 5.5% can be considered acceptable as regards cases of intolerance to the hydrogel and allergy to the film. The percentage of cases (5.5%) with abundant fibrin was also acceptable; the complication rate as regards the risk of infection and the presence of excessive scar tissue was higher (11.1% of cases).

Conclusion

Further in-depth clinical studies of the product are needed to establish:

• the time and method of medication in the acute and successive phases, in relation to the lesions;
• its effect on re-epithelialization and scar tissue.

Our personal recommendation is to use a semi-permeable membrane in order to prevent maceration of the cutis and permit the elimination of excess water, while keeping the active principle and the medication in place.

Evident advantages were noticed in this study with regard to pain control.

At present we do not possess follow-up data as regards scarring.

We propose to conduct a clinical study of the use in the acute and subsequent phases of sterile saline solution at 23 °C for 15 min followed by Burnshield®at 23 °C.

RESUME. Les lésions cutanées causées par les brûlures constituent un important problème. Quand elles sont profondes elles sont lentes à guérir et s’infectent, en outre elles causent des douleurs persistantes et portent à une cicatrisation inestéthique et à l’invalidité. Quand la brûlure est sévère, elle peut causer la mort à cause de diverses complications - septicémie, insuffisance rénale aiguë, syndrome de détresse respiratoire, insuffisance cardiocirculatoire, etc. Cette étude préliminaire a été effectuée dans des patients brûlés atteints de lésions cutanées dans un pourcentage de la surface corporelle qui normalement n’impose pas l’hospitalisation (> 10% dans les enfants, > 20% pour les adultes). L’efficacité analgésique du produit hydrogel contre les brûlures Burnshield R a été testée et après les études post-hospitalières les Auteurs ont intention d’évaluer les effets esthéthiques applications locales de Burnshield®. Ce produit a donné de bons résultats pour ce qui concerne son efficacité analgésique, qui était presque immédiate et persistante. Cependant, il faut encore effectuer des recherches sur le risque d’infection. La complication la plus fréquente était la macération de la peau, même si cela n’a pas nécessité l’interruption du traitement avec l’hydrogel.

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