The Gelfoam® plug: An alternative treatment for small eardrum perforations

Authors


  • The authors have no financial disclosures for this article.

  • The author have no conflicts of interest to declare.

Abstract

Aim:

To examine if a Gelfoam® plug in combination with surgical removal of the perforation edges could be an alternative to the widely accepted fat plug treatment for smaller ear drum perforations.

Materials and Methods:

A prospective study of 17 consecutive patients with persistent small ear drum perforations considered for myringoplasty. The perforations were central perforations 2 to 4 mm in diameter. Patient ages ranged from 6 to 83 years, and the operation was performed under general anesthesia with mask ventilation in children and under topical local anesthesia in adults. A Gelfoam® plug was inserted into the perforation after surgical removal of the perforation edges. The follow-up time was more than 3 months.

Results:

The closure rate of the ear drum was 83% (15/18). Pure tone average (PTA) was 19 dB preoperatively and 16 dB postoperatively.

Conclusions:

We show for the first time in humans that a Gelfoam® plug in combination with surgical removal of the perforation edges seems to result in about the same closure rate as the fat plug technique in persistent small ear drum perforations. Moreover, the method using Gelfoam® is simpler and faster than the fat plug technique. We suggest that randomized studies comparing the Gelfoam® plug technique with the fat plug technique should be performed. Laryngoscope, 2011

INTRODUCTION

Myringoplasty with temporal fascia is the “golden standard” for treatment of ear drum perforations. The closure rate after fascia myringoplasty is often more than 90%. In smaller ear drum perforations, however, this surgical technique is disputable. A common technique has been to trim the perforation edges, or to trim the edges together with the subsequent addition of a paper patch. This technique has a closure rate of about 43% to 67%.1–4 Because conventional myringoplasty with temporal fascia is time consuming, and because not all ENT specialists find it easy to perform, the fat plug technique is accepted as a good alternative for smaller perforations, with a closure rate of 80% to 90%.5–7 The fat plug technique consists of freshening the perforation edges and subsequently filling the perforation with a fat plug, harvested from the lobule of the outer ear, or from the subcutaneous tissues behind the ear. A recent article by Puterman and Leiberman8 suggested that the closure rate of the ear drum after removal of ventilation tubes was higher if the perforations were plugged with Gelfoam®.

The aim of the present pilot study was to investigate if this Gelfoam plug method could replace the fat plug technique in persistent small ear drum perforations.

MATERIALS AND METHODS

Seventeen consecutive patients with persistent small ear drum perforations were included in the study. One of the patients had a perforation in both ear drums, which is why the total number of perforations is 18. The duration of the perforations was more than 12 months, and the patients were referred to one of the authors (a.n.) for myringoplasty. The mean age of the patients was 27 years, and the size of the perforations varied from 2 to 4 mm. The cause of the persistent perforations was previous treatment with ventilation tubes in 12 out of 18 perforations (see Table I).

Table I. Age, Sex, Size of the Perforation, Cause of Perforation, Location, and General or Local Anesthesia
Patient (n)AgeSexSize (mm)CauseLocationAnesthesia
  1. vt = previous ventilation tube; post-MP = perforation after myringoplasty; G = general anesthesia; L = local anesthesia.

16f4vtant supG
268m3post MPpost infL
38m4+4vtant sup+ant supG
46m3vtant supG
580f3chron otitpost supL
683m2chron otitpost infL
77f2vtant supG
812f2chron otitant supG
958f2vtant infG
108f4vtant supG
1110f3vtpost infG
128m3vtant supG
1318m2barotraumapost infL
147m2vtant infG
157m3vtpost infG
1617m3vtant supG
1751m3chron otitpost infL

The surgery was performed under local topical anaesthesia of the ear drum with a 90% phenol solution in adults (n = 5), and under general anesthesia in one of the adults and in the children (n = 12). The edges of the perforation were surgically removed with a sharp needle and cupped forceps. A piece of Gelfoam® soaked in saline, approximately twice the size of the perforation, was inserted into the perforation in an hourglass shape (See Fig. 1). The stability of the plug was checked using a 1.0-mm suction tip (Mediplast®), and it was replaced with a larger plug if necessary. The patients were told to avoid water in the operated ear for 1 month. The patients were followed up with an audiogram (pure tone average [PTA] with frequencies of 0.5, 1.0, 2.0, and 4.0 kHz) and otomicroscopy 3 months postoperatively.

Figure 1.

The picture to the left shows an eardrum with a perforation indicated by a solid line. The dotted line indicates the trimmed edge that is removed. The picture to the right depicts the Gelfoam® plug in cross-section, inserted into the ear drum in an hourglass shape.

The study was approved by the ethics committee in Umeå (08–147 M) and the patients and/or the parents gave their informed consent.

RESULTS

The closure rate of the ear drums 3 months postoperatively was 83% (15/18). After healing, a small scar could be seen in the ear drum, but there were no atrophic areas at the location of the former perforation. We have no obvious explanation for the three perforations that did not heal. Neither the localization nor the size of the perforations could explain why they did not heal (see Table II).

Table II. Results after Gelfoam® Plug Surgery
Patient (n)ClosurePreopPostop
  1. Closure rates and pure tone average (PTA) pre- and postoperatively.

1yes106
2yes2830
3yes/yes10+1110+10
4yes1613
5yes4141
6yes6055
7yes94
8no18
9yes4141
10yes2018
11yes88
12yes1813
13yes64
14no1111
15no1610
16yes166
17yes2819
Total15/18 (83%)Mean = 19 dBMean = 16 dB

The mean preoperative PTA result was 19 dB, and the postoperative PTA result was 16 dB, so hearing was not significantly improved after surgery. There were no postoperative complications such as otorrhea or infections.

DISCUSSION

One of the most common reasons for persistent small ear drum perforations is long standing ventilation tubes in the ear drum. The golden standard for treating larger ear drum perforations is myringoplasty with temporal fascia as graft material. In smaller persistent ear drum perforations, however, the present surgical options for closure of the ear drum are:

  • 1Myringoplasty with temporal fascia. The closure rates with this method are often more than 90% (Swedish Quality Register, County of Norrbotten);
  • 2Insertion of a fat plug into the perforation after trimming the perforation edges. This is a popular method, especially for smaller perforations, and the closure rates are approximately 80% to 90%.5–7
  • 3Trimming of the perforation edges, with or without a paper patch over the perforation. For persistent perforations this method has the lowest closure rate of only about 50%.1–4

Because the fat plug technique and the fascia method have similar closure rates in persistent small perforations, the fat plug method is considered the method of choice due to its simplicity compared to conventional fascia myringoplasty.

In the present study we have shown that by using only a Gelfoam® plug it is possible to achieve a closure rate similar to rates reported in other studies using the fat plug technique. The procedure with Gelfoam® is easy and fast, which makes it possible to perform at an ordinary outpatient visit. We therefore suggest that Gelfoam® would be a better alternative than the fat plug technique. Randomized studies should be carried out to ensure that the Gelfoam® plug is as efficient as the fat plug. Although the present material is small, the closure rate of 83% indicates that it is at least in the same range as the fat plug closure rate of 80% to 90% in smaller perforations.

The present study presents a new indication for the method first presented by Hekkenberg and Smitheringale9 in 1995, and recently reported on by Puterman and Leiberman,8 who used a Gelfoam® plug after extubation of tympanostomy tubes. Using Gelfoam® in the middle ear has been questioned by some authors. In 1983, Hellstrom et al.10 reported increased fibrosis and bone formation in rats after Gelfoam® had been inserted in the middle ear. Joseph11 reported in 1962 on a study on dogs in which there was increased fibrosis in the area where part of the mucosa had been removed and that was in contact with Gelfoam®. On the other hand, in many countries Gelfoam® is routinely used as stabilizing material in every middle ear surgical procedure. Is it possible that the reported increase in connective tissue could be a positive effect when performing surgery on the tympanic membrane?

CONCLUSION

When surgery for persisting small tympanic membrane perforations is indicated, the choice has been between conventional myringoplasty with fascia and fat plug myringoplasty. The present study suggests that a Gelfoam® plug in combination with surgical removal of the perforation edges could replace the fat plug method. Further studies comparing the Gelfoam® plug and the fat plug are warranted.

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