Coagulation Abnormalities Following NexoBrid Use: A Case Report

Martín, Nuria Hinarejos; Guilabert, Patricia; Abarca, Luis Fernando Morales; Usúa, Gemma; Serracanta, Jordi Franch

doi:10.1093/jbcr/irx044

Cited by 12 publications

(6 citation statements)

References 7 publications

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“…Although other side effects apart from fever after application of enzymatic debridement have been reported in a single case report [14] the present study did not reveal any relevant adverse events after application, irrespective of the burn area.…”

Section: Discussioncontrasting

confidence: 74%

Safety of enzymatic debridement in extensive burns larger than 15% total body surface area

Hofmaenner

Steiger

Schuepbach

et al. 2021

Burns

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OBJECTIVES Bromelain-based enzymatic debridement has emerged as an alternative to surgical eschar removal. Indications include partial thickness, mixed pattern, and full-thickness burns. Enzymatic debridement has been approved by the European Medicines Agency for treating burn wounds affecting <15% total body surface area (TBSA). Data and evidence for the treatment of areas >15% TBSA in one session is scarce. The aim of this retrospective study was to retrospectively analyze off-label use of enzymatic debridement in a single burn center for large TBSA burns. METHODS Between 01/2017 and 12/2018, 59 patients with partial-to full-thickness burns underwent enzymatic debridement in a single center study. Patients were categorized into two groups: the regular use group with a treated area less than 15% TBSA and the off-label group (OG) with larger TBSA debrided in one session. Treatment was evaluated for systemic inflammatory reaction, bleeding, hemodynamic instability and electrolyte shifts. RESULTS In total, 49 patients were treated in the regular use group with a median application area of 6% (IQR 2.5-9.5) and 10 patients were treated in the off-label group with a median application area of 18% (IQR 15-19) TBSA. We found no significant differences regarding blood pressure, body temperature or hemodynamic stability during and after enzymatic debridement. No treatment-related serious adverse events were observed in either group. Catecholamine use was similar in both groups. No differences in leukocyte counts, CRP, PCT and lactate prior to application and during the following three days were observed. Sodium, potassium, chloride and phosphate levels did not differ. We found no evidence of an electrolyte shift. Survival was 49 of 49 patients (100%) in the RG and 7 of 10 patients (70%) in the OG (p = 0.004). CONCLUSION Enzymatic debridement did not result in any expected or unexpected side effects in the patient groups investigated. These preliminary results indicate the potential safety of bromelain-based enzymatic debridementin the treatment of burns greater than 15% TBSA.

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Section: Discussioncontrasting

confidence: 74%

Safety of enzymatic debridement in extensive burns larger than 15% total body surface area

Hofmaenner

Steiger

Schuepbach

et al. 2021

Burns

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“…The enzyme bromelain has been associated with coagulation abnormalities in in vitro and in vivo experiments, as well as after oral medication [104][105][106][107]. A case report of Martìn et al has already drawn attention to this subject in case of topical ED using a bromelain-based approach in burn injuries [108]. When performing ED, it can be recommended to critically evaluate the inclusion of patients with pre-existing risk factors for coagulation abnormalities such as established anticoagulant therapy, low platelet count, or an increased risk of active bleeding (e.g., due to sepsis or gastrointestinal haemorrhage).…”

Section: Results and Advantagesmentioning

confidence: 99%

Role, Development, and Value of Enzymatic Debridement as Integral Component in Initial Treatment of Burn Injuries Exemplified by NexoBrid®

Mattern

Fuchs

Schiefer

2022

EBJ

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Despite intensive research and increased knowledge over the past decades, the handling of severe burn injuries remains complex and is mainly based on clinical experience. High demands in terms of the diagnosis and choice of therapy often confront clinicians with challenging circumstances. Thus, the treatment of burn injuries has predominantly remained under the responsibility of specialised centres. As a new approach in addition to conventional surgery, enzymatically controlled debridement has come into focus for the treatment of burn injuries over the past years. The efficacy and safety of enzymatic debridement has already been implemented by numerous reputable studies. Promising results from the literature are enhanced by feedback from various conference contributions, intradisciplinary exchanges, and international collaborations. The implementation of enzymatic debridement in initial care management was found to be capable of reforming Standards of Care in numerous burn centres by facilitating treatment determinations and reducing the number of classical surgical interventions. Nevertheless, its use is also subject to certain restrictions as usage has shown limitations concerning efficacy when applied to scalds or pre-treated wounds. Enzymatic debridement shows high efficacy in terms of tissue debridement by combining this feature with the minimisation of collateral damage and a broad field of application in burn injuries. Due to their impressive performance in the treatment of burn injuries, enzyme-based techniques have also attracted attention for the treatment of other pathologies such as chronic wounds and are objects of ongoing research in this field. In this article, we illustrate the significance of enzyme-based treatment in initial burn care and shed some light on the potential value of enzymatic approaches in future burn surgery.

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“…11 This guidance arose from in vitro and animal studies, in which orally administered bromelain was found to reduce platelet aggregation and plasma fibrinogen concentration and to increase prothrombin and partial thromboplastin times. 10 However, it remains unclear whether topical application has similar effects. Martin et al 10 published a case of coagulopathy that occurred shortly after Nexobrid® use, with no reported bleeding.…”

Section: Discussionmentioning

confidence: 99%

“…9 The effects of enzymatic debridement upon coagulation are less clear. Martin et al 10 documented a case of marginally raised clotting times (prothrombin and activated partial thromboplastin ratio), 24 hours after application of Nexobrid® (6% total body surface area (TBSA) treated). There were no signs of active bleeding at that time and the significance of this finding is uncertain, as no other comparable cases have been reported.…”

Section: Introductionmentioning

confidence: 99%

To bleed or not to bleed? Case series and discussion of haemorrhage risk with enzymatic debridement in burn injuries

Hasham

Riyat

Fletcher

et al. 2023

Scars, Burns & Healing

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Introduction Surgical burn excision (along with skin grafting) carries the risk of blood loss. The use of enzymatic debridement agents such as Nexobrid® has gained increased popularity as an alternative to surgical debridement in the management of burns with its reported benefits of selective burn debridement, minimising blood loss and potentially reducing the need for skin grafting. However, there is limited evidence regarding its effects on bleeding. Currently, the manufacturer declares there is no evidence for increased risk of localised bleeding and its systemic effects upon coagulation are less clear. Methods We present two clinical cases demonstrating the possible effects of Nexobrid® on coagulation and bleeding at the debridement site. Comparisons are drawn with the manufacturers’ guidance as well as evaluating the current recommendations of its use. Discussion Nexobrid® is a novel therapy and there are few adverse effects reported in the literature. The basis of its appeal is the reduced blood loss at the debridement site and the selectivity it possesses in preserving healthy dermis. However, our cases have demonstrated that haemorrhage can occur and that those using Nexobrid® should be mindful of the potential bleeding risk from varicosities within the burn wound. We have also illustrated that Nexobrid® can be used in patients with pre-existing clotting disorders without requiring the use of blood products. However, we emphasise the importance of haematological support for its safe administration. Lay Summary Nexobrid®, a debriding agent that contains enzymes, has been developed as an alternative to surgery which for most surgeons is the traditional method of removing dead tissue following a burn injury. The active agent is bromelain and this is derived from the stems of pineapples. This novel treatment is increasingly being used in the management of middle to deep skin thickness burns and it seems to have a number of benefits such as reducing blood loss, reducing the need for skin grafting as well as being able to treat burns in certain areas of the body that would be technically challenging to remove in the standard fashion. It simply targets the dead tissue leaving viable remnants of the skin that would hopefully allow healing to occur without the need for surgical intervention. Being a relatively new concept, current evidence regarding the safety and value of Nexobrid® continues to develop. In 2020, an agreement guideline outlining best practice with the use of Nexobrid® was published. In this statement, it was advised that caution should be taken when using Nexobrid® in patients who have blood clotting disturbances as this could increase the likelihood of bleeding. However, they did not mention that excessive bleeding can potentially occur with this treatment. We present two clinical cases demonstrating the possible effects of Nexobrid® on the clotting system and bleeding at the application site. Comparisons are drawn with the manufacturers’ guidance as well as assessing the current recommendations of its use. We illustrate that Nexobrid® can be safely used in patients with pre-existing clotting disturbances if the correct procedures are performed. We also highlight the potential complication of excessive bleeding if Nexobrid® is used in patients who have co-existing enlarged surface veins along with their burn injury. We feel the guidance should be updated to reflect these findings.

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Coagulation Abnormalities Following NexoBrid Use: A Case Report

Cited by 12 publications

References 7 publications

Safety of enzymatic debridement in extensive burns larger than 15% total body surface area

Safety of enzymatic debridement in extensive burns larger than 15% total body surface area

Role, Development, and Value of Enzymatic Debridement as Integral Component in Initial Treatment of Burn Injuries Exemplified by NexoBrid®

To bleed or not to bleed? Case series and discussion of haemorrhage risk with enzymatic debridement in burn injuries

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