Overall Adverse Reactions
Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.
Hypersensitivity/Allergic/Anaphylactic Reactions: Hypersensitivity or allergic/anaphylactoid reactions may occur (see WARNINGS/PRECAUTIONS, Hypersensitivity/Allergic/Anaphylactic Reactions
). No adverse events of this type were reported during clinical trials.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported from a clinical trial where ARTISS was used to affix split thickness sheet skin grafts to excised burn wounds (see CLINICAL STUDIES). A total of 8 non-serious adverse reactions were deemed related to the use of ARTISS by the investigator. Of the 8 related non-serious adverse reactions, 5 were incidences of skin graft failure: 4 were graft detachment/non-adherence and 1 was graft necrosis. The graft detachment in 2 patients may have been related to the maximum thawing temperature (40°C) being exceeded during study product preparation. The 3 other non-serious adverse reactions considered related to ARTISS were 2 incidences of pruritus and 1 incidence of dermal cyst. The graft necrosis and the 2 cases of pruritus considered related to ARTISS each had an equivalent adverse reaction with the exact start date and severity reported at a control wound where skin grafts were affixed with staples. Therefore, these events are most likely not related to ARTISS, but instead are expected outcomes for any grafted wound regardless of the method of attachment.
Overall, the data collected and analyzed during this study demonstrated that ARTISS is safe for the attachment of sheet skin grafts in subjects with deep partial thickness or full thickness burn wounds.
The adverse reactions and their frequencies are summarized in Table 2:
Adverse reactions (Preferred Term)
Number of events/
Number of patients treated
|Skin graft failure
The following adverse reactions reflect what has been reported in post marketing experience with Baxter's fibrin sealant that could reasonably be expected to occur with ARTISS:
Immune system disorders: anaphylactic responses, hypersensitivity
Cardiac disorders: bradycardia, tachycardia
Respiratory, thoracic and mediastinal disorders: dyspnea
Gastrointestinal disorders: nausea
Skin and subcutaneous tissue disorders: urticaria
General disorders and administration site conditions: flushing, impaired healing, edema, pyrexia
Injury, poisoning and procedural complication: seroma
Air embolism associated with misapplication of fibrin sealant using the spray device, Class Effect: A postmarketing fatality was reported in association with the use of another fibrin sealant when applied using a spray device. The case involved an attempt to stop active bleeding by applying the fibrin sealant using a spray device attached to a wall unit at a higher than recommended pressure for the spray device. In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant. The patient suffered a fatal air embolism.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.