Role of albumin coating of tympanostomy tubes: long-term clinical evaluation.

OBJECTIVE: Our previous work has shown that albumin coating of tympanostomy tubes prevented adhesion of proteins or bacteria on the tube surface in vitro and in a 9-month prospective follow-up study. This study was continued until all tubes were extruded. STUDY DESIGN: A prospective, clinical trial. METHODS: The randomized, double-blind clinical trial had 149 patients. The randomization was revealed after the follow-up period of 9 months. The number of tube sequelae in ears with human serum albumin (HSA)-coated titanium tympanostomy tubes was compared with the contralateral ears with uncoated, otherwise identical titanium tubes. The follow-up continued until all tubes were extruded, followed by evaluation of each tympanostomized patient. RESULTS: No significant difference between the two tube types emerged after the 9-month follow-up. Among the patients younger than 2 years, one of the three typical bacteria causing acute otitis media (AOM), Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, was found in 45% of all bacterial cultures taken during AOM. However, among patients older than 2, one of these bacteria appeared in 17% of all the bacterial cultures and in 8% of cultures taken during the summer. CONCLUSIONS: After the first 9 follow-up months, no difference was found in the sequelae related to uncoated and HSA-coated tubes. The typical bacteria causing AOM were found less frequently among patients older than 2 years. A profile of tympanostomy patients in Finland will be given.

Albumin-coated tympanostomy tubes: prospective, double-blind clinical study.

OBJECTIVES: Coating an implant with albumin prevents adhesion of proteins, bacteria, and platelets and thus may lead to its improved and prolonged function. Previously, we have demonstrated the inhibition of binding of fibronectin, one of the most adhesive glycoproteins, on human serum albumin (HSA)-coated tympanostomy tubes and the durability of this binding inhibition in a 8-month trial. We have also demonstrated that the HSA coating inhibits the binding of Staphylococcus aureus and Pseudomonas aeruginosa to titanium plates. This prospective study evaluated the effect of albumin coating on tympanostomy tube sequelae and on the outcome of tympanostomized patients. STUDY DESIGN: Double-blind, prospective, randomized clinical trial. METHODS: Two otolaryngological centers in southern Finland enrolled 179 pediatric patients. Number of tube occlusions and otorrhea and tube ventilation time in the ears with HSA-coated titanium tympanostomy tubes were compared with the contralateral ear with its uncoated, otherwise identical titanium tube during a 9-month follow-up period. RESULTS: In HSA-coated tubes, average ventilation time was slightly longer and the number of early tube occlusions significantly less (P < .05). Moreover, in patients with perioperative bleeding, the coating prolonged average ventilation time of tympanostomy tubes significantly (P < .05). CONCLUSIONS: HSA coating reduces early tube occlusions by preventing adherence of blood and secretion.

Durability of the binding inhibition of albumin coating on tympanostomy tubes.

OBJECTIVE: Occlusion and prolonged otorrhea are typical problems associated with the use of middle-ear ventilation tubes. Albumin coating of ventilation tubes has been introduced to prevent tube occlusions by granulation tissue, blood clot, or pus. In this study, the durability of the binding inhibition (BI) of fibronectin was examined on the tube surface in albumin-coated tubes in different environments during an 8-month trial. METHODS: Human serum albumin (HSA) was used to coat silicone tympanostomy tubes. Fibronectin, a typical adhesive protein in serum and exudates, was used as a model representative of exudates of the ear. The durability of BI of this glue protein on the tube surface was tested in different time periods with radiolabelled fibronectin. Scanning electron microscopy (SEM) was performed on the tubes. RESULTS: The BI of fibronectin, achieved with the albumin coating, was still strong after 8 months of storage at +4 degrees C. A slight decline in BI was noted between the first and third months of storage at +37 degrees C. A significant difference between HSA-coated and uncoated tympanostomy tubes was noted in SEM. The uncoated surface generally appeared to be rougher than that of HSA-coated tubes when either titanium or silicone tubes were tested. CONCLUSIONS: Albumin coating markedly inhibits the binding of fibronectin on tube surfaces in vitro. A clear BI achieved by albumin coating on tube surfaces was shown to persist throughout an 8-month trial, although some reduction of the BI was seen over time. The result emphasizes the role of albumin coating in preventing the adherence of foreign material on tympanostomy tubes. No advantage was achieved by using a cross-linking chemical in the albumin coating.

Acute central nervous system complications in varicella zoster virus infections.

BACKGROUND: In a previous multicenter study on central nervous system (CNS) viral infections varicella zoster virus (VZV) appeared the most frequent etiologic agent and appeared often without rash. OBJECTIVE: To evaluate the appearance and diagnostics of VZV in CNS more thoroughly, we studied the cases systematically by using sensitive and specific methods to learn the best diagnostic approach in order to start specific therapy. STUDY DESIGN: We analyzed all serum and cerebrospinal fluid samples of 174 patients, 88 females and 86 males, with acute CNS symptoms associated with VZV infection diagnosed in the multicenter study on viral CNS infections. RESULTS: About 38 patients (22%) had chickenpox, 59 (34%) had shingles, and 77 (44%) had no cutaneous symptoms at all. The mean age of chickenpox patients was 8.6 years, of the others 46.6 and 41.4 years. VZV-specific nucleic acid was detected in the CSF in one fourth of the patients in all groups, primarily during the first week of illness. In serum specimens, specific IgM was present in two thirds of the patients with chickenpox, whereas in the others in one third of the cases. In CSF, specific IgM was present in 15-17% of patients with skin manifestations, compared with 6% of those without rash. CONCLUSIONS: The role of VZV infections in CNS complications seems remarkable, often presenting without rash. Even these cases should be promptly recognized in order to conduct proper antiviral therapy. In children, a combination of PCR and IgM tests is the best approach. In adults, PCR, together with the measurement of intrathecal antibody production yields best results.