Stimulation of epithelial healing in chronic postoperative otorrhea using lyophilized cultured keratinocyte lysates.

Objective: After tympanoplasty, despite a closed tympanic graft, some patients continue to have persistent otorrhea due to insufficient epithelial healing and granulation tissue formation in the depths of the outer ear canal. When all medical therapies fail, many otologists undertake revision surgery, usually with free skin grafting. To avoid surgery, the authors sought to improve this condition with a lysate of lyophilized cultured allogeneic keratinocytes. Study Design and Patients: In this prospective pilot study, lyophilized cultured allogeneic keratinocyte lysates have been administered in 27 patients. These patients had uncontrollable otorrhea that resisted medical (topical) therapy for at least 6 months. Main Outcome Measure: The criterion of success was a complete epithelialization and cessation of otorrhea. Results: After an average of 2 applications, cessation of otorrhea was achieved in 20 cases (74%). Three patients (11%) relapsed after 3 months. The other ears (63%) still were dry at the 1-year final evaluation. Conclusions: These results are similar to those obtained after application of sheets of viable cultured keratinocytes of autologous as well as of allogeneic origin. Because the soluble lysate can be incorporated into ototopical drops, the lysate technique is more "user-friendly" and can be applicable in any outpatient clinic. Because keratinocytes contain many growth factors (e.g., epidermal growth factor, basic fibroblast growth factor, platelet-derived growth factor, transforming growth factor), the authors speculate that the release of those intracellular growth factors is responsible for the observed therapeutic effect. This form of therapy by its combination of several growth factors might be considered a more physiologic method than the, also still experimental, growth factor therapy in which high doses of only single growth factor are used.