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

    loading  Checking for direct PDF access through Ovid

Abstract

Objective

Assessment of differences in soft tissue healing and long-term issues between two techniques for bone-anchored hearing implant (BAHI) surgery.

Study Design

Single-center, randomized, nonblinded study using balanced randomization (1:1).

Setting

Tertiary referral center in the Central Denmark Region.

Patients

Forty-seven adults with normal skin quality.

Intervention

Operation with a BAHI system with randomization to 1) dermatome technique with soft tissue removal and 2) linear incision with no soft tissue reduction.

Outcome Measures

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.

Results

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 · 10−16; 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.

Conclusion

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.

Related Topics

    loading  Loading Related Articles