Elsevier

Burns

Volume 30, Issue 8, December 2004, Pages 843-850
Burns

Safety and efficacy of a proteolytic enzyme for enzymatic burn débridement: a preliminary report

https://doi.org/10.1016/j.burns.2004.04.010Get rights and content

Abstract

A prospective, non-comparative study design was used to describe our experience with a bromelain-derived debriding agent, Debridase, in 130 patients with 332 deep second degree and third degree burns treated between 1984 and 1999. Debridase was applied after saturating the burns with a moist dressing for 2–24 h. Debridase was applied for a period of 4 h under an occlusive dressing. Mean patient age was 18.6 ± 19.3, 42 (32.3%) were female, and 63 (48.5%) were children under age 18. Most burns were small. Debridase was applied once in 241 (72.6%) of the 332 wounds, twice in 67 (20.18%) cases, three times in 12 (3.61%) cases, and four times in 2 (0.6%) cases. The percentage débridement by number of applications was 89 ± 21% for a single application, 77 ± 27% for two, and 62 ± 27% for three Debridase applications, respectively. There were no significant adverse events. The availability of a fast acting, reliable and complication-free enzymatic debriding agent may open new horizons and provide a new treatment modality for burns.

Introduction

One of the major characteristics of burns is the formation of an eschar, which is made up of burned and traumatized tissue. The presence of the eschar that covers the entire injured area prevents accurate diagnosis of the burn's depth and may lead to the extension of injury to neighboring, originally undamaged tissues. The eschar also serves as a medium for bacterial growth, and is therefore a source of infection, contamination and sepsis. As a result, prompt removal of the eschar is imperative to the healing of burns [1], [2], [3], [4], [5].

The current method of choice for burn débridement is surgical tangential excision as advocated by Janzekovic in 1970 [6]. While effective, surgical débridement has several major disadvantages. Tangential excision is non-selective and may sacrifice healthy surrounding tissues, often converting a partial thickness burn into a full thickness defect [1], [6], [7], [8]. Furthermore, surgical excision is painful and exposes patients to the risks of repeated anesthesia and significant bleeding. Enzymatic débridement has been suggested in the past, however the agents used have had several drawbacks. In particular, most enzymatic agents require prolonged and repeated exposures in order to achieve sufficient débridement often necessitating further surgical or chemical débridement. Furthermore, repeated applications, especially when using moist occlusive dressings for extensive periods of time, may result in local infection and promote systemic spread of the infectious process [9], [10], [11], [12], [13].

The ideal débridement agent or method should have the following attributes:

  • 1.

    Safety: i.e., without any systemic adverse effects and minimal if any bleeding.

  • 2.

    Selectivity: resulting in removal of the necrotic eschar without affecting the surrounding viable tissue, thus permitting accurate diagnosis of the extent of the original damage.

  • 3.

    Effective: removing the entire eschar, preferably in a single application.

  • 4.

    Rapid: resulting in rapid reduction of the infection risk and permitting sequential débridement of large areas over a short time span.

  • 5.

    Simple to use and cost effective.

Bromelain is a well-known group of enzymes extracted from pineapple fruits or stems. It contains more than 50 different components and is widely used as an over-the-counter food additive and is also used in the cosmetic industry. The late Drs. Klein and Houck, [14], [15] attempted to debride burn eschars with bromelain. They initially used commercially available lyophilized preparations achieving good but inconsistent results [16], [17], [18]. Further work led to the development of a proprietary extraction method that purified active ingredients from the crude bromelain to obtain a highly effective debriding mixture that they called “Debridase” [19]. The developers claimed that the effective action of Debridase was due to the synergistic activity of its various components.

We have been using and evaluating Debridase for more than 15 years for the débridement of deep second and third degree burns in our burn unit. The current study summarizes our results.

Section snippets

Materials and methods

A prospective non-comparative study design was used to evaluate our experience with Debridase in over 250 consecutive burn patients between 1984 and 1999. All study patients gave written informed consent and the study was approved by the national and local hospital ethics committees.

Results

During the study period more than 250 consecutive patients were treated with Debridase, however, complete records were available for only 130 patients with 332 wounds. The patients’ mean age was 18.6 ± 19.3, 42 (32.3%) were female, and 63 (48.5%) were children under age 18. Approximately half of all burns were caused by contact with fire or flame. Other etiologies included scalds (47), contact burns (17). Most burns (66%) covered less than 10% of TBSA. Burns covering 10–30% TBSA accounted for

Discussion

The concept of débridement is as old as medicine itself. The first reference to débridement appears in the Old Testament. The prophet Isaiah is quoted: “‘Take a bunch of figs’ They took and placed the figs on the ulcer and Hezekiah recovered.” Christopher Columbus also described the use of pineapple juice to promote healing [20]. Although the importance of the débridement is well-accepted, there is no clear definition of how much healthy tissue should be sacrificed in order to achieve adequate

Conclusions

We present our preliminary results using the enzymatic debriding agent “Debridase” for deep burns. We found that in most cases complete débridement of the eschar was obtained after only one to two brief applications with minimal side effects and no blood loss. No specific Debridase-related morbidity or mortality was noted. The availability of a rapid, reliable and complication-free enzymatic debriding agent may open new horizons and provide a new treatment modality for burns.

Acknowledgments

The study was initiated in 1983 in the Soroka Burn Unit at the request of Drs. Klein and Houck who donated the Debridase enzyme. In 1992, the study GMP material was produced and donated by Biotechnology General LTD Israel (BTG Ltd.). None of the authors had any financial interests in the company at the time of the study (1983–1999). Since January 2002, the primary author (LR) acts as the Chief Medical Director of MediWound Ltd. that produces the new batches of Debridase under the name of

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