To investigate the use of a new technique to close persistent tympanic membrane perforations under general anaesthesia, in patients in whom this has previously been considered impractical.
Twenty patients aged 50 years and over were recruited. All had a persistent, symptomatic tympanic membrane perforation in at least one ear. Pre-operatively, an audiogram was performed and the tympanic membrane was assessed in order to establish the site and size of the perforation. Under general anaesthesia, the edges of the perforation were freshened and a sheet of Epifilm, trimmed to a size roughly 2 mm larger in diameter than the perforation, was tucked through the perforation. The ear was dressed appropriately. Patients were seen two weeks post-operatively in the out-patients department and reassessed.
The study was based at Poole General Hospital, a District General Hospital.
Twenty patients were recruited from the out-patients clinics of Poole Hospital ENT department.
(1) closure of the perforation, as a percentage of the original size; (2) improvement of hearing, as an average across all frequencies, expressed in dB hearing level; and (3) presence or absence of discharge.
Five patients were operated upon and assessed six weeks post-operatively. The Epifilm had dissolved but the perforations remained the same size in all five patients. There were no other adverse effects. Pure tone audiometry at this stage was redundant. The study was subsequently aborted.
The authors conclude that repair of tympanic membrane perforations with hyaluronic acid ester films is not to be recommended.