Comparing Gelfoam vs. fat as a sealing material in stapedotomy; A prospective double blind randomized clinical trial

Abstract

Objectives

One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example; adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot, and soft connective tissue. Up to now, there has been no randomized clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material.

Design

This prospective, double blind, randomized clinical trial was carried out on ears that had undergone stapedotomy.

Setting

Dasthgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology center in southern Iran.

Participants

A total of 176 primary stapedotomies were analyzed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears.

Main outcome measures

pre‐operative and post‐operative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated.

Results

Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative ABG within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5‐3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs. 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P>0.05). In addition, there was no case of dead ear in either group.

Conclusions

We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short term follow up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.

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