M. Brent Seagle

Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP.

The goal of this prospective randomized clinical trial was to compare 2 cohorts of standardized cleft patients with regard to functional speech outcome and the presence or absence of palatal fistulae. The 2 cohorts are randomized to undergo either a conventional von Langenbeck repair with intravelar velarplasty or the double-opposing Z-plasty Furlow procedure. A prospective 2 × 2 × 2 factorial clinical trial was used in which each subject was randomly assigned to 1 of 8 different groups: 1 of 2 different lip repairs (Spina vs. Millard), 1 of 2 different palatal repair (von Langenbeck vs. Furlow), and 1 of 2 different ages at time of palatal surgery (9–12 months vs. 15–18 months). All surgeries were performed by the same 4 surgeons. A cul-de-sac test of hypernasality and a mirror test of nasal air emission were selected as primary outcome measures for velopharyngeal function. Both a surgeon and speech pathologist examined patients for the presence of palatal fistulae. In this study, the Furlow double-opposing Z-palatoplasty resulted in significantly better velopharyngeal function for speech than the von Langenbeck procedure as determined by the perceptual cul-de-sac test of hypernasality. Fistula occurrence was significantly higher for the Furlow procedure than for the von Langenbeck. Fistulas were more likely to occur in patients with wider clefts and when relaxing incisions were not used.

Evaluation and treatment of velopharyngeal insufficiency: The University of Florida experience

This retrospective study spans the years 1988 to 2000 and looks specifically at the treatment procedures and outcomes for the correction of velopharyngeal insufficiency (VPI). Ninety-eight patients underwent preoperative assessment by speech pathologists that included perceptual speech evaluation, videofluoroscopy, and, for some, nasendoscopy. Based on this evaluation protocol, a specific surgical procedure was chosen to serve the patients’ needs. The four procedures of choice were the palatal pushback with a pharyngeal flap lining, sphincter pharyngoplasty, a superiorly based obturating pharyngeal flap, and Furlow palatoplasty. The criteria for selecting these procedures are reviewed. The results revealed VPI resolution and the establishment of normal nonnasal speech in more than 95% of the 75 patients for whom outcomes were determined. This study reiterates the importance of thorough preoperative evaluation and the individualization of the secondary corrective procedure.

A review of the surgical and medical treatment of Frey syndrome.

Frey syndrome represents a fascinating example of how nerve regeneration can go awry. The syndrome is characterized by profuse facial sweating and flushing that occurs when salivation is stimulated. It can develop following a variety of insults but is most commonly encountered as a complication of parotidectomy. Consequently, it is mainly head and neck surgeons who see and treat this disorder; however, it is important for other clinicians to recognize what these unusual symptoms represent. Diagnosis may be based either on clinical presentation or through objective testing methods. Potential negative social and psychologic implications of this condition can be significant, and treatment ranging from topical agents to local injections of botulinum toxin (Botox) to surgical intervention should be offered to patients. In this article, we present an up-to-date review of the surgical and medical treatment of this syndrome.

Palatal fistula repair using acellular dermal matrix: the University of Florida experience.

Palatal fistulas represent a challenging problem for surgeons caring for patients with cleft palate. The purpose of this study was to examine the rate of fistula closure using conventional surgical techniques (Group 1) versus a newer technique (Group 2) employing the use of acellular dermal matrix (AlloDerm). We reviewed the charts of all patients who underwent palatal fistula repair between July 1994 and February 2005. The surgical techniques in Group 1 varied and were considered a historical control. In the second group, a piece of dermal matrix was interposed between the nasal and oral mucoperiosteum after closure of these layers. The primary fistula closure rate for Group 1 was 83.3% (10/12 patients). Fistula closure was obtained in 100% of the patients in Group 2. There were no complications noted other that the failure of the 2 patients in Group 1. The use of AlloDerm in palatal fistula repair has reduced our failure rate from 16.7% to 0%. The use of AlloDerm during palatal fistula repair is safe, effective over time, and has the potential to reduce palatal fistula recurrence rates.

Otologic and audiologic outcomes with the Furlow and von Langenbeck with intravelar veloplasty palatoplasties in unilateral cleft lip and palate.

Objective Cleft palate increases the risk of chronic middle ear disease and hearing loss. The goal of this report was to determine which of two palate surgeries and which timing of palate surgery were associated with better otologic and audiologic outcomes in children with unilateral cleft lip and palate at 5 to 6 years of age. Design Subjects were randomly assigned to the von Langenbeck with intravelar veloplasty or Furlow palate repair, to palate surgery at 9 to 12 months or 15 to 18 months of age, and to the Spina or Millard lip repair. Setting Centralized, tertiary care craniofacial treatment center. Patients A total of 673 infants with unilateral cleft lip and palate. Interventions Palate and lip were repaired using established techniques. Serial otoscopic and audiometric evaluations were performed. Main Outcome Measures Hearing and otoscopic findings at 5 to 6 years old. Results There were 370 children available for analysis. Hearing and need for tympanostomy tube placement did not differ by palatoplasty, age at palatoplasty, cheiloplasty, or surgeon. Risk of developing cholesteatoma or perforation was higher with Millard cheiloplasty (odds ratio = 5.1, 95% confidence interval = 1.44 to 18.11, p = .012). Type and age at palatoplasty were not significantly associated with either the rate of developing these sequelae or the rate of achieving bilaterally normal hearing and ear examinations. Conclusions Type of palatoplasty did not influence otologic and audiologic outcomes in 5- to 6-year-olds with unilateral cleft lip and palate. The potential influence of lip repair on otologic outcomes warrants further investigation.

A methodology report of a randomized prospective clinical trial to assess velopharyngeal function for speech following palatal surgery

Cleft lip and palate occurs in approximately 1 in every 750 live human births, making it one of the most common congenital malformations. Surgical closure of the palatal cleft does not always result in a velopharyngeal port capable of supporting normal speech. The University of Florida (UF), in collaboration with the University of São Paulo (USP), is engaging in a 5-year prospective, randomized controlled study to compare velopharyngeal function for speech outcomes between patients undergoing palatoplasty for complete unilateral cleft lip and palate performed using the von Langenbeck procedure with intravelar velarplasty and those receiving the Furlow double-reversing Z-plasty palatoplasty. The von Langenbeck procedure was selected as the time-tested standard against which the Furlow procedure could be judged. The Furlow procedure, a relatively new operation, has been reported to yield substantially higher rates of velopharyngeal competency for speech than have most other reported series and theoretically should result in less disturbance to midfacial growth. A total of 608 patients will be entered into one of two age categories. Inclusion of two age groups will allow a comparison of results between patients having surgery before 1 year of age (9-12 months) and patients undergoing surgery at approximately 1.5 years of age (15-18 months). Speech data will be collected and will be available for definitive analysis throughout the last 3 years of the study. Collection of preliminary growth data will require more than 5 years; growth analysis is anticipated to continue until all patients have reached maturity. The Hospital for Research and Rehabilitation of Patients with Cleft Lip and Palate at the University of São Paulo (USP-HPRLLP) in Bauru, Brazil, is uniquely situated for conducting this study. The well-equipped and modern facilities are staffed by well-trained specialists representing all disciplines in cleft-palate management. In addition, an already existing social services network throughout Brazil will ensure excellent follow-up of study cases. The clinical caseload at this institution currently exceeds 22,000, and more than 1200 new cases are added annually. This project represents a unique opportunity to obtain prospective data from a large number of subjects while controlling the variables that have traditionally plagued cleft-palate studies. This study is designed to determine which of the two proposed surgical procedures is superior in constructing a velum capable of affecting velopharyngeal competency for the development of normal speech.

Promoting a culture of patient safety: a review of the Florida moratoria data: what we have learned in 6 years and the need for continued patient education.

Patient safety and medical error reduction are topics of extreme importance. Although there has been considerable media controversy regarding reports of decreased patient safety and errors that have occurred in operating rooms of hospitals, ambulatory surgery centers, and doctors’ offices, the majority of data across various specialties demonstrate a very low incidence of adverse events resulting from office-based surgery. Limited research has been conducted in patient safety on the topic of outpatient surgery. Since the release of the Institute of Medicines (IOM) report To Err Is Human, significant progress has been made in patient safety. According to the IOMs report in 2000, between 48,000 and 98,000 annual US hospital deaths result from medical errors. Following the report, there have been numerous calls to improve patient safety and place it at the forefront of the national agenda. The Florida Board of Medicine restricted office procedures in 2000 after a series of incidents occurred in the outpatient setting. The objectives of this paper are to review the Florida moratoria data over the last 6 years to discuss what we have learned as a specialty and to continue a culture of safety in plastic surgery. One of the remaining challenges is the need to continually improve this culture of safety and emphasize the need for continued patient education, specifically related to esthetic procedures administered in nonclinical settings by amateur, unlicensed, or unqualified practitioners, with a misrepresentation of their credentials and training. This is a long-term proposition and one that has been driven foremost by our leaders in plastic surgery.

Otologic and Audiologic Status of Russian Children with Cleft Lip and Palate

OBJECTIVE In this study, researchers evaluated the otologic and audiologic status of 112 children with repaired cleft lip and palate who had received primary palatal repair by means of Frolova palatoplasty, a surgical technique developed by Dr. Larisa Y. Frolova, founder and director of the National Pediatric Center for Congenital Maxillofacial Pathology, Moscow, Russia. DESIGN Results of hearing thresholds and tympanograms for these Russian children were compared with data previously reported from a group of 48 children and adults with repaired cleft lip and palate at the University of Florida Craniofacial Center, Gainesville, Florida. RESULTS There were no substantial differences in hearing thresholds between the two groups, which was surprising in view of the vast differences between middle ear management techniques used in Russia and the United States. CONCLUSIONS Considering these findings and the growing body of literature favoring a more conservative approach to the management of middle ear effusion in infants with cleft lip and palate, a reexamination of otologic strategies in the United States seems advisable.