Double-Layer Traction Method for Treating Severe Upper Auricular Adhesion Malformation in Infants: A Prospective Randomized Controlled Study.

Abstract

Severe upper auricular adhesion malformation poses a significant challenge for complete correction through ear molding. This prospective randomized controlled study aimed to assess the efficacy of a new method in addressing severe upper auricular adhesions. In this non-blinded randomized controlled study, we enrolled 72 infants with severe upper auricular adhesion malformation who underwent treatment with the EarWell system. They were randomly assigned to either the double-layer traction (DLT) group or the control group. We compared the effectiveness of treatment, treatment duration, and potential complications between the two groups. All 72 infants completed the treatment and follow-up, with 38 (52.8%) in the DLT group and 34 (47.2%) in the control group. The DLT group exhibited significantly shorter treatment times and a lower incidence of pressure sores than the control group. The DLT method, along with unilateral malformation, independently predicted positive long-term outcomes. The DLT method demonstrated superior effectiveness, shorter treatment duration, and lower complication rates than traditional methods when treating severe upper auricular adhesion malformation in infants. The DLT method is safe and effective and merits broader adoption in clinical practice. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.