Common questions about NexoBrid (FAQ)
Q: How quickly does NexoBrid start working on the burn area?
A: Official information indicates that the active enzyme component of NexoBrid is rapidly absorbed into the bloodstream from the burn wound after application. The median time it takes for the concentration to reach its highest level in the blood is about four hours, which corresponds with the required duration of the treatment application.
Q: What's the main benefit of using NexoBrid compared to traditional burn treatment?
A: Clinical studies reviewed by regulatory bodies showed that using NexoBrid was associated with a shorter time to remove the dead tissue (eschar) from the burn wound. Additionally, the studies indicated a lower incidence of needing surgical excision compared to patients treated with the standard of care.
Q: How does NexoBrid know which tissue to remove?
A: NexoBrid's active ingredient uses proteolytic enzymes that are designed to selectively target and break down the denatured proteins—such as collagen and fibrin—that make up the burn eschar. This mechanism allows for the removal of the non-viable tissue, as the enzymes are designed to be selective and minimize damage to the surrounding viable tissue.
Q: How long does the NexoBrid treatment process usually take?
A: The product is required to be left on the burn wound for a fixed duration of four hours to allow the enzymatic process to complete. The entire treatment process, which includes the necessary preparation, application, and subsequent removal and wound cleansing procedures, will take longer than this contact time.
Q: Will I need skin grafts even if I use NexoBrid?
A: Regulatory documents reviewing clinical trial data showed that NexoBrid use significantly reduced the incidence of surgical excision and the percentage of deep partial-thickness wound area requiring autografts compared to the standard of care. The subsequent need for skin grafting is a clinical decision made by the treatment team based on the wound's condition after eschar removal.
Q: Is it normal to have swelling or redness after NexoBrid application?
A: The official product safety information lists pruritus (itching) and pyrexia (fever) as common side effects seen in clinical trials. A rash has also been reported in some patients. Swelling is not listed among the most commonly reported adverse reactions in the regulatory documents.
Q: Is there an age limit for who can receive NexoBrid?
A: According to official product information, NexoBrid is indicated for use in all age groups, including both adults and pediatric patients from birth through 18 years old. However, there are different restrictions on the maximum burn size (Total Body Surface Area or TBSA) that can be treated at one time for younger children.
Q: Does NexoBrid interfere with pain medicines given for burns?
A: Official documents do not list specific drug interactions with general pain medications. However, regulatory warnings emphasize that the enzymatic debridement and removal processes are painful. Therefore, adequate analgesia and/or anesthesia are necessary to manage pain before, during, and after the application of NexoBrid.
Q: Does NexoBrid leave a better scar than surgery?
A: Long-term follow-up studies reviewed by regulatory agencies monitored patient outcomes using standardized scar assessment tools. These studies found that the cosmetic and functional outcomes in the NexoBrid group were generally considered non-inferior to those achieved in the standard of care (surgery) group at both 12 and 24 months post-treatment.
Q: Why do doctors choose NexoBrid over surgical debridement sometimes?
A: Regulatory summaries of clinical trials indicate that NexoBrid offers a non-surgical method to achieve rapid and effective removal of dead tissue. Clinical data showed that it achieved this with a lower incidence of needing surgical excision and with less blood loss compared to standard surgical methods.
Q: Is NexoBrid available in all hospitals that treat burns?
A: Official labeling states that NexoBrid should only be applied by trained healthcare professionals in specialist burn centers. Therefore, its use and availability are restricted to these specialized hospital settings.
Q: Can I breastfeed while being treated with NexoBrid?
A: Regulatory documents state that there is no data on whether the medicine is present in human milk or what effects it might have on a breastfed child. For this reason, regulatory bodies note that caution should be considered if the medicine is administered to a nursing woman.
Q: Why is proper wound care so important after NexoBrid treatment?
A: After the dissolved tissue is removed, the regulatory guidelines emphasize that the debrided area needs to be covered immediately with appropriate dressings or skin substitutes. This is required to prevent the wound from drying out (desiccation), which is crucial for successful healing and avoiding infection.
Q: Does NexoBrid require a special type of dressing?
A: Yes. According to official administration instructions, the treated wound must be covered with a sterile occlusive film dressing during the four-hour application time. Following the removal of the product, the area is then covered with a dressing soaked in an antibacterial solution for two hours.
Q: Can NexoBrid be used for chemical burns or electrical burns?
A: No. Official labeling clearly states that the safety and effectiveness of NexoBrid have not been established for the treatment of chemical or electrical burns. For this reason, regulatory documents state the product is contraindicated for these specific types of wounds.
Q: Does NexoBrid hurt when it's applied?
A: Regulatory warnings indicate that enzymatic debridement is a painful procedure. To manage this, official instructions require that adequate analgesia and/or anesthesia be administered to the patient both before the application and during the removal of the product.
Q: Are patients awake when NexoBrid is used?
A: The official product information specifies that the procedure is painful and requires adequate pain management, including the use of analgesia and/or anesthesia. Clinicians will determine the specific level of pain relief needed, which may involve sedation, based on the patient's condition.
Q: What does the area look like right after NexoBrid treatment?
A: Official instructions describe the necessary final step after the dissolved eschar is wiped away. The treated area is typically rubbed until the wound bed displays a pinkish surface with small bleeding points or a whitish tissue to confirm that the dead tissue has been successfully removed.
Q: What happens if NexoBrid gets on the eyes or mucous membranes?
A: While specific instructions for eye/mucous membrane contact are not explicitly detailed, the official handling guidelines state that in the event of accidental skin exposure, the product is generally advised to be rinsed off with water. This action is intended to reduce the potential for skin irritation or sensitization.
Q: What are the signs of a serious allergic reaction to NexoBrid?
A: Regulatory documents highlight the potential for serious allergic reactions, including anaphylaxis. Signs of such reactions may include a rash, widespread redness (erythema), and a sudden drop in blood pressure (hypotension) or rapid heart rate (tachycardia).
Q: Why do some people need two applications of NexoBrid?
A: For adults, the initial application is limited to a maximum of 15% of the Total Body Surface Area (TBSA). A second application may be considered by the burn team 24 hours later if the patient has additional burn wounds that need treatment, provided the total cumulative area treated does not exceed 20% TBSA.
Q: Can NexoBrid be used on parts of the body with very thin skin?
A: Regulatory documents state that the safety and effectiveness of the medicine have not been established for burns on the face, perineum, or genitalia. These areas are often complex or have very thin skin, and therefore, clinical caution is typically considered.
Q: Why is it important to treat the burn within a few days using NexoBrid?
A: Clinical studies showed that NexoBrid was able to achieve faster eschar removal compared to standard treatments. In burn care, timely removal of the eschar is generally considered critical for reducing the risk of complications like infection and for creating the best possible environment for wound healing.
Q: Can older patients handle the NexoBrid treatment well?
A: Official information indicates that clinical experience in elderly patients (age 65 years and older) is limited. However, regulatory documents specify that based on the available data, no specific dose adjustment is required for this age group.
Q: Does using NexoBrid shorten the patient's hospital stay?
A: Clinical studies reviewed by regulatory agencies demonstrated a shorter time to complete eschar removal and faster wound closure compared to the standard of care. These factors are typically associated with a reduced overall duration of acute care.
Q: Are there any food restrictions while undergoing burn treatment with NexoBrid?
A: NexoBrid is contraindicated (must not be used) in patients with a known severe allergy or hypersensitivity to the active substance, bromelain, or any components derived from the pineapple or papaya plant. The care team typically needs to be informed of all known allergies, especially those related to the product's components.
