Novocure opinion is that the contribution of the array placement to wound dehiscence cannot be ruled out.Contributing factor for wound dehiscence in this patient include: prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound dehiscence was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in the optune/tmz arm of the trial (<1%) only.
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A 66 year old female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2022.Novocure was informed on (b)(6) 2023, that during a transducer array change, the patient observed what appeared as exposed cranial hardware on the scalp in the location of previous surgery.An image provided, revealed exposed cranial hardware on the surgical resection scar (last surgical resection (b)(6) 2022).On (b)(6), 2023, the patient's caregiver reported the patient had surgery to remove four plates and a bone.Optune therapy was temporarily discontinued.According to the discharge summary provided by the prescribing physician, the patient was hospitalized on (b)(6) 2023, for elective surgery to remove exposed cranial hardware of the right parietal cranial plates, irrigation, and debridement of the right parietal scalp.Infectious disease was consulted and antibiotics (ceftriaxone and daptomycin) were administered via a peripherally inserted central catheter (picc) line.The postoperative course was uncomplicated, and the patient was discharged home in good condition on (b)(6) 2023.On (b)(6) 2023, the prescriber assessed the event as related to optune therapy.
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