產品資訊

“美迪文”清創凝膠藥 (NexoBrid®)

“美迪文”清創凝膠藥 (NexoBrid®)

適應症請參考仿單
NexoBrid
產品資訊

 中文仿單
NexoBrid®英文官網：https://www.nexobrid.com/。
NexoBrid使用程序：

 
相關文獻:
  1. Eschar removal by bromelain based enzymatic debridement (Nexobrid®) in burns: European consensus guidelines update. Hirche C, Kreken Almeland S, Dheansa B, Fuchs P, Governa M, Hoeksema H, Korzeniowski T, Lumenta DB, Marinescu S, Martinez-Mendez JR, Plock JA, Sander F, Ziegler B, Kneser U. Burns. 2020 Mar 30. pii: S0305-4179(19)30897-6. doi: 10.1016/j.burns.2020.03.002. [Epub ahead of print]
  2. The enzymatic debridement for the treatment of burns of in-determinate depth. Bernagozzi F, Orlandi C, Purpura V, Morselli PG, Melandri D. J Burn Care Res. 2020 Mar 30. pii: iraa051. doi: 10.1093/jbcr/iraa051. [Epub ahead of print]
  3. Feasibility and safety of enzymatic debridement for the prevention of operative escharotomy in circumferential deep burns of the distal upper extremity. Fischer S, Haug V, Diehm Y, Rhodius P, Cordts T, Schmidt VJ, Kotsougiani D, Horter J, Kneser U, Hirche C. Surgery. 2019 Jan 21. pii: S0039-6060(18)30799-2.
  4. Time to start putting down the knife: A systematic review of burns excision tools of randomised and non-randomised trials.Edmondson SJ, Ali Jumabhoy I, Murray A. Burns. 2018 Nov;44(7):1721-1737.
  5. An Overview of the Use of Bromelain-Based Enzymatic Debridement (Nexobrid®) in Deep Partial and Full Thickness Burns: Appraising the Evidence. Loo YL, Goh BKL, Jeffery S. J Burn Care Res. 2018 Oct 23;39(6):932-938.
  6. The entity of thermal-crush-avulsion hand injury (hot-press roller burns) treated with fast acting debriding enzymes (nexobrid): literature review and report of first case. Di Castri A, Quarta L, Mataro I, Riccardi F, Pezone G, Giordano L, Shoham Y, Rosenberg L, Caleffi E. Ann Burns Fire Disasters. 2018 Mar 31;31(1):31.
  7. Eschar removal by bromelain based enzymatic debridement (Nexobrid ®) in burns: An European consensus. Hirche C, Citterio A, Hoeksema H, Koller J, Lehner M, Martinez JR, et al. Burns. 2017 Dec;43(8):1640-1653.
  8. Enzymatic debridement of deeply burned faces: Healing and early scarring based on tissue preservation compared to traditional surgical debridement. Schulz A, Fuchs PC, Rothermundt I, Hoffmann A, Rosenberg L, Shoham Y, Oberländer H, Schiefer J. Burns. 2017 Sep;43(6):1233-1243.
  9. Bromelain-based enzymatic debridement and minimal invasive modality (mim) care of deeply burned hands. Krieger Y, Rubin G, Schulz A, Rosenberg N, Levi A, Singer AJ, Rosenberg L, Shoham Y. Ann Burns Fire Disasters. 2017 Sep 30;30(3):198-204.
  10. Enzymatic debridement for the treatment of severely burned upper extremities - early single center experiences. Cordts T, Horter J, Vogelpohl J, Kremer T, Kneser U, Hernekamp JF. BMC Dermatol. 2016 Jun 24;16(1):8.
  11. Minimally invasive burn care: a review of seven clinical studies of rapid and selective debridement using a bromelain-based debriding enzyme (Nexobrid®). Rosenberg L, Shoham Y, Krieger Y, Rubin G, Sander F, Koller J, David K, Egosi D, Ahuja R, Singer AJ. Ann Burns Fire Disasters. 2015 Dec 31;28(4):264-274.
  12. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. Burns. 2014 May;40(3):466-74.
  13. Selectivity of a bromelain based enzymatic debridement agent: A porcine study. Rosenberg L, Krieger Y, Silberstein E, Arnon O, Sinelnikov IA, Bogdanov-Berezovsky A, Singer AJ. Burns. 2012 Nov;38(7):1035-1040.
  14. Efficacy of enzymatic debridement of deeply burned hands. Krieger Y, Bogdanov-Berezovsky A, Gurfinkel R, Silberstein E, Sagi A, Rosenberg L. Burns. 2012 Feb;38(1):108-12.
  15. Reepithelialization of mid-dermal porcine burns after rapid enzymatic debridement with Debrase®. Singer AJ, Taira BR, Anderson R, McClain SA, Rosenberg L. J Burn Care Res. 2011 Nov-Dec;32(6):647-53.
  16. The effects of rapid enzymatic debridement of deep partial-thickness burns with Debrase on wound reepithelialization in swine. Singer AJ, Taira BR, Anderson R, McClain SA, Rosenberg L. J Burn Care Res. 2010 Sep-Oct;31(5):795-802.
相關文件
檔案名稱上次更新下載
NexoBrid_中文仿單2021-10-18下載
NexoBrid介紹小冊子2022-07-27下載
NexoBrid 使用前快速檢查表2023-07-10下載
NexoBrid 操作步驟快速指引2023-12-18下載
Post NexoBrid Diagnosis2023-07-10下載
Pain Management2023-07-10下載
Wound Management After NexoBrid2023-07-10下載
Role of NexoBrid in Burn Mass Casualty Incidents (BMCI)2023-07-10下載
NexoBrid使用注意事項2023-12-15下載
Q & A
[Q] Does NexoBrid harm viable healthy tissue, especially when apply for more than 4hrs?
[A] In general no, especially for several hours. In more than 8-10 hours the healthy skin may be irritated and itchy. In burn care there is no reason to increase the time of NexoBrid application.
[Q] If the application of NexoBrid on burn wound >4 hrs, for example extend accidentally to 6 hrs or longer, will there be any harm to the patient? Although we know the NexoBrid enzyme activity will decrease gradually after mixing, is there any concern on the extended application time?
[A] We did not encounter any ill effect of longer than 4 hours applications. However, we found that there is no benefit in longer than 4 hours. Another issue is that keeping a dissolved eschar inside an occlusive dressing (that both are prone to infection) on the skin with the skin adnexa that are sources of germs and contamination longer than necessary may be not a good idea.
In the NexoBrid IFU says "To prevent possible irritation of abraded skin by inadvertent contact with NexoBrid, and possible bleeding from the wound bed, acute wound areas such as lacerations or escharotomy incisions should be protected by a layer of a sterile fatty ointment or fatty dressing (e.g. petrolatum gauze)". Why the abraded skin and acute wound areas need to be protected from contacting NexoBrid?
NexoBrid applied into escharotomy incisions where exposed blood vessels with intact but burned walls or blood vessels occluded by thrombi that were transected during escharotomy may cause bleeding by NXB dissolving them. So these incisions should be protected by fatty ointments or gauze. As application of NXB on abraded skin may be a little painful EMA (European Medicines Agency) asked to insert this warning.
[Q] Should “silver sulfadiazine or betadine” be avoided at all cost before the Enzymatic Debridement (ED)?
[A] “silver sulfadiazine or betadine” be avoided at all cost before the ED, as it may interfere with the enzymatic activity reducing its effect in burn eschar that is saturated with such products. Products that mummify the eschar (i.e. Cerium nitrate derivates like Flamacerium etc.) will greatly reduce NexoBrid’ enzymatic effect. Soaking with solutions containing silver or iodine also will saturate the eschar making it resistant to enzymatic activity. Dry eschar either by desiccation or by carbonization may also be hard to dissolve. Often flame burns may be covered by carbonized epidermal keratin that will insulate the eschar from NexoBrid’ enzyme.
[Q] The NexoBrid IFU/SOP says pain management is needed 15 minutes prior to application and the removal of NexoBrid. Is this enough? Is there a need of additional pain management during the 4 hrs NexoBrid application period?"
[A] The application pain (described usually as a burning pain) starts immediately when NXB touches the areas of exposed dermis: superficial burns that are usually at the edges of the burn. This is the reason that analgesia/sedation should start before the application. As the enzymes work their way through the eschar the deeper burns may become sensitive as well for 30-60 minutes. Thereafter, the application pain starts to slowly subside. The feeling during the removal stage, wiping the dissolved eschar and NexoBrid’s remains, is different. It is not a burning pain but more dull and is due to the pressure/mechanical action of the wiping tongue depressor or spatula on the viable wound bed and should be prevented before.
However, as in any pain management, the individual patient attitude makes a difference. The patient should be prepared that he may feel such pains and in well prepared, very cooperative patients they may not need analgesia. In such a well prepared and cooperative patient a PCA (patient controlled analgesia) may be quite effective. The easiest way (unless one wants to knock down the patient completely by general anesthesia) is to dose the analgesia following patient’s reaction. A diluted Propofol or Ketamine – Midazolam. These are fast acting drugs that will prevent procedural pain and allow easing the patient medication when the treatment is not painful. I highly recommend these two strategies as they will allow the burn team to better understand the actual application-related-pain in function of the 4 hour treatment process.