Collagen matrix as a replacement for Gelfilm® for post-tympanostomy tube myringoplasty.

OBJECTIVE

Gelfilm® is no longer available for use in myringoplasty. We have substituted a commercially available collagen matrix (Biodesign® Otologic Repair Graft) for Gelfilm® as on onlay patch after removal of retained tympanostomy tubes. We compare the effectiveness of these two materials for post-tympanostomy tube myringoplasty.

METHODS

Surgeries were performed in the same manner by residents supervised by the same surgeon during consecutive time periods. Tympanostomy tubes were removed under general anesthesia using a pick and cup forceps. Margins of the resultant perforation were rimmed and a patch placed on the lateral surface of the drum to cover the perforation. Children were seen at 4 weeks after surgery. Tympanic membrane closure was assessed by otoscopy and tympanometry. Patient age at time of myringoplasty, laterality (right/left/bilateral), and presence or absence of a persistent perforation at one month follow-up were tabulated. Total duration of tympanic intubation, tube design and material, reason for tube removal, and additional risk factors (trisomy 21, cleft palate, midfacial anomalies) were analyzed.

RESULTS

55 children met inclusion criteria. 28 children (36 ears) were patched with Gelfilm®. 27 children (35 ears) were patched with collagen matrix. Median ages at surgery and duration of intubation were similar in the two groups. There were persistent perforations at 4 weeks in 5/28 children (5/36 ears, 14%) with Gelfilm®, and 3/27 children (3/35 ears, 9%) with collagen matrix. There was no significant difference in the rate of persistent perforation between the two materials by Fisher's exact test by patients (p = 0.7049) or by ears (p = 0.7101; OR: 1.72; 95% CI 0.38-7.82).

CONCLUSION

Gelfilm® and collagen matrix patches performed similarly in the operating room. Rates of tympanic membrane closure were comparable in this pilot study. Larger patient numbers will be needed to prove equivalence or superiority of collagen matrix for this application.