Objective: To determine the effects of applying a natural polymer solution (shellac) to dry gangrene, and thereby prevent infection and progression to wet gangrene, in diabetic patients.
Methods: This randomized, controlled, pilot study included patients with type 2 diabetes mellitus who had unreconstructable peripheral vascular disease and were awaiting autoamputation. Eligible patients were contraindicated for surgery, had a limited life expectancy and/or had refused surgical amputations. All patients received the best possible medical treatment and were randomized to receive either topical shellac or antiseptic application of 10% povidone-iodine (PVP-I) solution to gangrenous areas.
Results: A total of 26 diabetic patients were eligible for inclusion, of whom 23 completed the study: 13 were treated with shellac and 10 with PVP-I. The amputation rate was higher in the conventional treatment group versus the shellac group (60.0% versus 46.2%, respectively), although this difference was not statistically significant.
Conclusions: Shellac is a natural solution that may be used to embalm gangrenous tissue in selected diabetic patients. More studies are needed to assess the long-term outcomes of this technique.
Keywords: Shellac; amputation; diabetes mellitus; gangrene; ischaemia.