In-office Repair of Chronic Tympanic Membrane Perforations

Background

The use of topically applied growth factors to promote TM closure has been suggested as an attractive alternative to conventional tympanoplasty. Previous clinical studies have reported a 92% and 98% complete closure rate of chronic tympanic membrane perforations with application of topical FGF-22 (Hakuba et al., Kanemaru et al). The investigators recently published a study a double-blinded, randomized placebo-controlled phase 2 clinical trial of 54 patients with chronic TM perforations also applying topical FGF-2 with saline as the control. Unlike prior studies the investigators found no statistically significant difference between FGF-2 (57.5%) and saline control TM (71.4%) closure rates (P value = 0.36).

The current study is proposed to examine healing rates with topical application of FGF-2 with surgical modifications to our prior study in the attempt to mirror the Japanese studies excellent results. The long-term goal is to repair TM perforations with nonsurgical topical application of the appropriate factors to avoid surgery, general anesthesia, and hospitalization. A secondary aim is to maintain hearing and to prevent complications of TMP.

Surgical modifications in this limited study of 20 patients randomized to active (FGF-2) or placebo (saline) treatment include 1) ensuring that no middle ear discharge is present at the time of the procedure, 2) placing a cotton pledget in the middle ear prior to rimming the perforation, 3) removing any tympanosclerotic tympanic membrane that abuts the perforation, 4) placing a layer of test article in the middle ear medial to the perforation and lateral to the perforation prior to adding a fibrin glue, 5) using up to 4 applications of the test article, and 6) the procedure will be performed by one surgeon only to ensure complete adherence to prescribed techniques and reduce surgeon variability.

Specific Aims and Objectives