Evaluation of effectiveness of three-dimensional printed ear splint therapy following ear elevation surgery in microtia patients: A randomized controlled trial.

Aim: This study aimed to compare the effectiveness of a 3D-printed ear splint with that of a conventional thermoplastic ear splint after microtia reconstruction.

Methods: Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included. They were randomly divided into the experimental group (3D-printed ear splint) and the control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy. Splint therapy was initiated 4 weeks postoperatively and continued until 24 weeks postoperatively. The evaluated indices were the Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction. A two-group t-test was carried out to compare all variables except patient satisfaction, which was compared using the Mann-Whitney U-test; p < 0.05 was considered significant.

Results: Twenty patients were included in each group. At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups. At 24 weeks postoperatively, the mean VSS scores were 4.85 ± 1.46 and 6.25 ± 1.74 (p = 0.009), the mean cranioauricular distances were 15.80 ± 1.82 mm and 13.95 ± 1.93 mm (p = 0.004), and the patient satisfaction scores were 4.5 ± 0.51 and 3.7 ± 0.47 (p < 0.001) in the experimental group and the control group, respectively, all showing significant differences. Two patients in each group exhibited skin irritation or skin ulcers, which resolved after 6 months of follow-up.

Conclusion: The application of 3D-printed ear splints provides better inhibition of scar contracture, better maintenance of ear projection and higher patient satisfaction than conventional ear splints following ear elevation surgery in microtia patients. Therefore, 3D-printed ear splints should be preferred over conventional ear splints whenever possible.