ABSTRACT
Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.
ABSTRACT
OBJECTIVE: To evaluate tolerance and efficiency of two nasal blocking systems for posterior refractory epistaxis. PATIENTS AND METHODS: A five year comparative and longitudinal prospective study was developed in patients with epistaxis who attended our Emergency Unit and who required posterior nasal packing. Two groups were considered: one group was treated with a bi-chamber pneumatic inflation system (n=105). In other one, posterior occlusion was carried out with gauze, accessing through the mouth and using nasal reinforcement (n=47). The tolerance was measured by means of an analogue scale of pain intensity during the placement and maintenance of the packing, as well as for the need of analgesia. The efficiency was evaluated by episodes of re-bleeding, need for other concomitant measures, blood transfusion and side effects. RESULTS: In patients with inflatable nasal packing its placement was significantly faster (36+/-19s vs. 228+/-102 s; p<0.001) and less painful (6.7+/-1.7 vs. 8.3+/-1.5; p<0.001), requiring less analgesia until its removal. Patients with pack of gauze showed a lower average incidence of re-bleeding (17% vs. 26 %; p<0.001), fewer cases of blood transfusion (15% vs. 18%; p<0.001) or of other procedures (4% vs. 11 %; p<0.001). The sanitary cost of the latter was also lower (1327+/-202 euro vs. 1648+/-318 euro; p<0.001) and it generated less short and long-term complications CONCLUSIONS: The classical posterior packing with gauze is less rapid and comfortable to adapt, but it ensures a higher success rate in the control of epistaxis, produces fewer local injuries and reduces sanitary costs in comparison with inflatable balloon packing.
Subject(s)
Emergency Treatment/methods , Epistaxis/therapy , Hemostatic Techniques , Tampons, Surgical , Adult , Aged , Female , Humans , Male , Middle Aged , Prospective StudiesABSTRACT
Se presentan nueve casos de tumor de Warthin afectando a la glándula parótida, estudiados desde un punto de vista clínico, radiológico e histopatológico. Se discuten los aspectos más interesantes en el diagnóstico de esta entidad. En todos ellos se practicó sialografía y estudio radioisotópico. El seguimiento medio efectuado fue de dos años y nueve meses tras el tratamiento quirúrgico, que se practicó en todos los casos, no existiendo recidiva alguna. Tan sólo en un caso se apreció paresia del facial superior homolateral, que desapareció posteriormente con tratamiento médico
