Bone-anchored Hearing Implant Surgery: Randomized Trial of Dermatome Versus Linear Incision Without Soft Tissue Reduction--Clinical Measures.

Abstract

Assessment of differences in soft tissue healing and long-term issues between two techniques for bone-anchored hearing implant (BAHI) surgery. Single-center, randomized, nonblinded study using balanced randomization (1:1). Tertiary referral center in the Central Denmark Region. Forty-seven adults with normal skin quality. Operation with a BAHI system with randomization to 1) dermatome technique with soft tissue removal and 2) linear incision with no soft tissue reduction. Holgers' score, pain, and sensibility loss assessed at 0, 3, 7, 10, 14, and 21 days and 1, 3, 6, and 12 months postoperatively. Implant loss. Forty-nine patients were randomized (linear incision, n = 25; dermatome, n = 24). Forty-seven patients were analyzed (linear incision, n = 25; dermatome, n = 22). Differences in proportions for grouped data (outcome 0 and outcome >0) for the total of all visits were Holgers' Index: 0.13 (p = 0.0004; 95% confidence interval [95% CI], 0.058-0.21); sensibility loss: 0.50 (p = 2.2 · 10; 95% CI, 0.42-0.58); pain: 0.096 (p = 0.006; 95% CI, 0.026-0.17). Soft tissue reactions and pain were most prominent in the early postoperative period, whereas issues with sensibility loss subsided throughout the 1-year follow-up period. No implants were lost. In a randomized trial for BAHI surgery, the linear incision with no subcutaneous reduction had a faster healing time and inflicted less pain and sensibility loss than the dermatome technique. The long-term soft tissue problems were similar in the two groups, thus favoring the linear incision, which is less invasive.