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; 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.
RCT Entities:
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; 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.
Authors: Ruben M Strijbos; Christine A den Besten; Emmanuel A M Mylanus; Myrthe K S Hol Journal: Eur Arch Otorhinolaryngol Date: 2016-04-16 Impact factor: 2.503