AdvaCoat™ Sinus Gel Study

Chronic rhinosinusitis (CRS) is a very common condition, affecting 35 million Americans each year. Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure that opens up the sinus and alleviates the symptoms of CRS patients. A common unwanted side effect of the FESS procedure is the formation of adhesions between the septum and the middle turbinate, preventing proper ventilation and drainage from the paranasal sinuses. Clinically, relevant adhesions form in 5-20% of all patients undergoing FESS procedures.

The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat™ sinus gel; a nasal dressing that conforms to mucosal surfaces and prevents adhesion formation following endoscopic ethmoid sinus surgery. AdvaCoat™ is a bioresorbable hyaluronan gel, thus eliminating the pain and tissue abrasion caused by removal of non-absorbable nasal packing. In addition to preventing scars, AdvaCoat™ serves as an adjunct to aid in the natural healing process by controlling bleeding and minimizing edema. This prospective, multi-center, randomized, controlled study will also be compared to MeroGel® Injectable, a commercially approved absorbable nasal dressing.

Propofol-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Sleep apnea is a common disorder that affects more than 12 million Americans. People with sleep apnea experience transient cessation of respiration during their sleep, with each interval lasting for 10 seconds or more. While a range of non-surgical treatments is available, including medications, behavioral changes, continuous positive airway pressure, or mouthpiece, many have opted surgery as a solution. Currently, the decision on the type of surgery suitable for a patient is determined through medical history and physical examinations, X-rays, endoscopic examinations and other resources while a patient is awake.

The purpose of this study is to determine whether a propofol-induced sleep endoscopy can improve our understanding on the patterns of blockage of breathing during sleep. As the patient sleeps, we are able to witness their typical breathing patterns exhibited at night. Our goal is to observe the throat to see how and where the airway is blocked and to determine if this technique provides important, unique information.

PCR Analysis of Nasal Polyps for Fungal DNA

Nasal polyps are soft growths projecting from the mucous membrane of the sinuses and are often caused by chronic sinus disease. Inflammation of the sinuses causes blood vessels to be more permeable to water, allowing for fluid retention and through time, polyp formation. Nasal polyps are the result of chronic inflammation, which maybe set up by allergies, molds, fungus and/or bacterial or viral infections.

This study aims to find out if any specific type of fungus or mold is correlated with chronic sinus disease. Patients enrolled in the study will have their nose swabbed with a cytology brush and will be asked to bring in their vacuum bag to be swabbed as well. The specimens collected will be sent to Stephen Vesper, PhD, of US Environmental Protection Agency Office of Research and Development, in Cincinnati, Ohio, for analysis. We hope that this study will add new insight about chronic sinus disease and the different types of fungus and mold found in the human nose. 

Effects of Anti-IgE Antibody Omalizumab (Xolair™) on Patients with Chronic Sinusitis and a Positive Allergen Test.

Sinusitis is defined as inflammation of the lining membrane of any of the paranasal sinuses. In a large group of patients with sinusitis, allergic inflammation appears to be one factor that plays an important in both acute and chronic sinusitis. Clinical studies have also shown a high prevalence of sinus disease in patients with allergic rhinitis. Furthermore, in patients with nasal polyps and chronic sinusitis, 71% have asthma. The inflammatory process between chronic sinusitis and asthma has shown some consistent parallels. Recently, Xolair™, an injectable medication of recombinant anti-IgE that blocks the allergic cascade, has been approved as a new treatment for asthma.

The purpose of this study is to learn more about possible treatments for chronic sinusitis.  We will evaluate the effectiveness of Xolair™, as a potential treatment for people suffering from chronic sinusitis and allergies. Xolair™ has been shown to effectively treat allergic rhinitis and the inflammation associated with the disease, although it is not approved for that purpose. Because of the similarities between the inflammatory processes found in asthma and rhinitis to those in chronic sinusitis, we predict that sinusitis should respond to Xolair™, just as asthma. This clinical trail is being done because currently, even with the surgical and medical treatments available, there are many patients who still suffer from chronic sinusitis.

Microarray analysis of sinus samples from patients with and without chronic rhinosinusitis.

Acute rhinosinusitis is a common, infectious, debilitating disease and the responsible bacteria have been well described. However, the pathophysiology of chronic rhinosinusitis (CRS) remains enigmatic. Multiple factors, including allergy, inflammation, physical obstruction of outflow tracts, and various microorganisms have been implicated. The microbiology of CRS continues to be debated, and prior studies have been limited by sampling technique, culture methods, and the inherent heterogeneity of the disease.

This pilot study analyzes mucosal biopsies and samples of mucus from the maxillary sinus using genetic microarray technology. Specimens will be collected from patients with and without CRS during surgery and the samples will be given to Susan Lynch, PhD, who works closely with Dr. Boushey in the Division of Allergy and Immunology. The use of microarray technology, which has not previously been applied to sinus microbiology, will provide insight on the type of pathogens present in patients with and without CRS. This technology allows for more accurate identification of microorganisms and can give us more knowledge about their relative contribution to CRS patients.

A ChemoSensory Questionnaire (CSQ) for Patients Treated for Cancer of the Head and Neck

Objective: To investigate primary chemosensory issues experienced by patients who undergo treatment for cancer of the head and neck and to develop and assess a ChemoSensory Questionnaire (CSQ).

Design: Cross sectional survey for questionnaire development and testing.

Methods: Literature, expert opinion and focus group methodology were used to identify aspects of smell and taste affecting patients before, during, and after therapy for cancer of the head and neck. A draft instrument was compiled, reviewed and revised. The revised instrument was administered along with a demographic and clinical form, the SF-12, the Performance Status Survey, and the University of Michigan Head and Neck Quality of Life Questionnaire to a sample of patients. Following item and scale analyses and reductions, a final instrument was assembled. Construct validity and test-retest reliability were assessed. Results: 206 patients were included in the study. The final survey instrument consisted of 8 items, 4 on smell and 4 on taste. Cronbach’s alpha was 0.89 for the smell scale and 0.78 for the taste scale. Correlations with other HRQOL scales ranged from 0.20 to 0.64 for the taste scale and from 0.10 to 0.33 for the smell scale. Good construct validity of the CSQ scores was demonstrated.

Conclusions: Treatment for head and neck cancer negatively impacts smell and taste. A survey instrument was developed to evaluate chemosensory function that is simple to administer and brief. This instrument will be of value in identifying factors that contribute to chemosensory disturbance and may serve as a guide for planning treatment regimens that minimize such disturbance.

Additional studies are planned to prospectively assess chemosensory disturbance in patients treated for cancer of the head and neck.

Acupuncture for the Treatment of Chronic Sinusitis

Chronic sinusitis is a common disease, with over 34 million cases in the United States alone. Patients suffer significant morbidity reporting a quality of life similar to that seen in patients with chronic heart disease, angina pectoris, and chronic obstructive pulmonary disease. Conventional approaches utilized in western medicine include medications such as antibiotics and steroids with surgery as an adjunctive treatment in selected cases. While patients experience significant relief from such treatments, relapses do occur and many patients seek treatment outside of traditional western medicine.

Despite the large number of patients seeking treatment for chronic sinus/nasal symptoms, very little information exists regarding the treatment patterns and efficacy of complementary treatment. In an effort to improve understanding of the role of acupuncture in the treatment of chronic sinusitis, the Center is collaborating with the UCSF Osher Center for Integrative Medicine. Ongoing projects include a survey of Bay Area acupuncturists regarding their treatment practices and beliefs about the role of acupuncture in the treatment of sinus/nasal symptoms. A prospective, randomized study is underway to evaluate the efficacy of acupuncture in the treatment of chronic sinusitis. Outcome measures will include general and disease specific questionnaires as well as CT scans and standardized endoscopic evaluations. For questions or further information regarding the study please contact the center: ccro@ohns.ucsf.edu.

The Role of Biofilms in Chronic Sinusitis

Biofilms are a structurally complex community of bacteria attached to a surface through a gelatinous extracellular matrix that work together to infect the body, evade antibiotics, and resist the immune system. A recent study has preliminarily confirmed the presence of biofilms on mucosal surfaces in humans with chronic rhinosinusitis (CRS). The purpose of this prospective, controlled study is to evaluate the prevalence, microbial constituents, and structure of biofilms in patients with chronic rhinosinusitis. Transmission electron microscopy and very high power light microscopy are among the techniques being used for analysis. Methods for identification of the organisms present are being developed.

CT Imaging for Sinusitis - Reformatted vs. Direct Coronal Imaging

Direct coronal CT images are important in both the evaluation and surgical planning for sinus disease. The coronal plan allows clear imaging of the medial orbital wall, the skull base, the uncinate process, and the ethmoid labyrinth, all key landmarks in sinus surgery. Axial images may be reformatted for coronal visualization, but these reformatted images may contain significant artifact or lack the resolution for accurate evaluation of the key sinus landmarks. As many patients undergo axial imaging for image guidance procedures, this study aims to determine whether direct coronal imaging adds significant information when compared to reformatted coronal imaging for surgical planning and intraoperative use.

HIV and Squamous Cell Carcinoma of the Head and Neck - A Clinical Study

Squamous cell carcinoma (SCC) is the most common malignancy of the upper areodigestive tract (UADT). Patients with UADT SCC appear to have a more rapidly progressive clinical course. Previously studies have suggested a younger age of onset and worse prognosis for HIV-positive patients with UADT SCC when compared with their HIV-negative counterparts. The goal of this study is to examine and compare the clinical course of HIV-positive and HIV-negative patients with UADT SCC through case control comparison.

Endoscopic Post-Cricoid Advancement Flap for Posterior Glottic Stenosis

Posterior glottic stenosis represents a challenging clinical condition for which numerous procedures are available to improve airway obstruction. The endoscopic postcricoid advancement flap has been described as useful adjunct for treatment of posterior glottic stenosis, employing an endoscopic method for placing vascularized tissue in the posterior glottis to prevent scar re-formation. The procedure minimizes trauma through use of an endoscopic approach rather than a midline thyrotomy and can be performed with available microlaryngeal equipment by surgeons familiar with laryngeal microsurgery. A review of the application of this technique is being performed to better identify patients with posterior glottic stenosis who are appropriate candidates for the procedure.

Uvulopalatopharyngoplasty (UPPP) Resource Utilization Study

UPPP is often one of the first steps recommended to adult patients seeking a surgical approach to ameliorating obstructive sleep apnea. The perioperative mortality and serious morbidity rates are very low for this operation. Some authors have suggested that overnight hospitalization following uvulopalatopharyngoplasty is unnecessary. This recommendation principally takes into account complications rates and not patient comfort and levels of pain in the postoperative period. While outcomes following UPPP at our institution have similarly low morbidity and mortality, paralleling the outcomes reported in the literature, patients undergoing UPPP appear to require a high level of care, utilize inpatient services extensively and that overnight hospitalization may be appropriate on this basis. This report provides a quantifiable retrospective review utilizing prospectively collected data of our experience with the hospital admission of these patients with attention to utilization of hospital resources and patient comfort. This study will investigate the resource utilization of patients undergoing UPPP and assess appropriateness of hospital care in the postoperative period.

Impact of socioeconomic status on the diagnosis to treatment interval in Waldeyer's ring carcinoma.

OBJECTIVE: To examine the impact of socioeconomic status on the diagnosis to treatment interval in Waldeyer's ring cancers by comparing the experience of a public hospital and an academic tertiary care medical center.

DESIGN: Retrospective review.

SETTING: Otolaryngology clinic of a public hospital and an academic medical center.

PATIENTS: One hundred seven patients with Waldeyer's ring carcinoma who were diagnosed and treated at San Francisco General Hospital (SFGH) or at the University of California, San Francisco Medical Center (UCSFMC) from January 1995 through December 2000 were included in the study. The same departments of otolaryngology-head and neck surgery and radiation oncology staff both hospitals. All radiation therapy was provided at UCSFMC. Patients included in the study had a histologic diagnosis of Waldeyer's ring carcinoma, primary treatment with radiation, and no prior treatment of Waldeyer's ring carcinoma.

MAIN OUTCOME MEASURES: The time of diagnosis to start of radiation therapy, dose of radiation, number of treatment days, duration of treatment, and 1 and 3 year survival were recorded. Differences between the two groups were analyzed using Student's t test. RESULTS: The time course from diagnosis of nasopharyngeal carcinoma to start of radiation therapy was 56 days at SFGH compared with 34 days at UCSFMC. This difference was statistically significant (P = .0001). Difference in diagnosis to treatment intervals for base of tongue cancer was also significant at 66 days at SFGH compared with 31 days at UCSFMC (P = .0038). For cancer of the tonsil, the diagnosis to treatment interval was 70 days at SFGH versus 40 days at UCSFMC (P = .0005). Dose of radiation, number of days of treatment, and duration of treatment were not statistically different. Only patients with cancer of the tonsil demonstrated a statistically significant difference in 3 year survival (P = .0175).

CONCLUSION: Although radiation therapy delivery appears similar between the public and tertiary care medical centers, there appears to be a statistically significant delay in the initiation of therapy for patients at the public institution. It is possible that this influences 3 year survival in cancer of the tonsil.

Additional studies are planned to prospectively evaluate the reasons for the increased DTI for patients at SFGH.

Intraoral versus Extraoral Repair of Mandible Fractures

Mandible fractures are the second most common facial fracture. The aim of treatments of mandible fractures by transoral or extraoral approach is rapid healing by optimized reduction and fixation in order to restore function and appearance with minimal disability and complications. Extraoral approach to mandible fractures of the posterior mandibular body, angle and ramus improves visualization of the fracture site and thus improves reduction or repair resulting in improved overall outcome, and fewer complications. On occasion, cases that are begun with the intraoral approach are converted to the extraoral approach for improved visualization, and thus actually increase overall operative time. Our study was a retrospective chart review of 100 patients with isolated mandible fractures treated at a level one trauma center, the San Francisco General Hospital, from January 2000 to January 2004. Cases were evaluated for cause, age, gender, dentition, site, extent of fractures, surgical approach, postoperative complication, timing to repair, operative time, and postoperative occlusion. By comparing the two main approaches to the mandible (transoral and extraoral) for their advantages and disadvantages, we plan to recommend a reasonable treatment algorithm for mandible fracture repair.

Acoustic pharyngometry and pressure-flow measurements in a cadaver model: A novel tool to evaluate sleep apnea procedures

The interest in providing more effective surgical treatments for obstructive sleep apnea has resulted in a wave of innovative and pioneering work. An obstacle to their implementation is the difficulty in interpreting some of the outcomes studies, which are often retrospective and contain numerous confounding factors. The aim of the present study is to develop a cadaver model to help provide the rationale for these novel sleep apnea procedures. Acoustic pharyngometry, a research instrument that converts acoustic signal data to distance-area curves, and pressure-flow measurements are performed to demonstrate changes in cross-sectional area and compliance of the pharynx.