Porcine small intestinal submucosa (SIS) myringoplasty in children: A randomized controlled study.

INTRODUCTION: A novel bioactive material for tissue graft, derived from porcine small intestinal mucosa (SIS) has been marketed. This material promotes early vessel growth, provides scaffolding for the remodeling tissues, and is inexpensive and ready-to-use. We evaluated efficacy, safety, and surgery time of SIS myringoplasty, in comparison with autologous temporalis fascia (PTF) repair in children in a prospective, two-group (SIS and PTF) randomized, blinded study at a tertiary-care pediatric institution. MATERIALS AND METHODS: 404 children with tympanic membrane (TM) repair were randomly assigned to receive SIS or PTF myringoplasty. Primary outcome was the healing of the TM at 6 months. Secondary outcomes were surgical time, and adverse events. Long-term follow-up ranging from 11 to 2 years was obtained in all enrolled children. Audiometric tests as pure-tone thresholds were applied in all patients. The Fisher's exact test and the Kriskal-Wallis test were applied for statistical analysis. RESULTS AND DISCUSSIONS: Four-hundred-thirty-two TM perforations were treated, 217 in the SIS and 215 in the PTF groups. There were 209 stable TM closures in the SIS (96.3%) and 204 (94.8%) in the PTF arm. This difference was not statistically significant (odds ratio=0.4, 95%; confidence interval=0.12-1.41). SIS myringoplasty yielded reduced surgical time. No adverse reaction to SIS was encountered. Audiometric tests revealed no statistically significant difference in the two groups. CONCLUSIONS: SIS myringoplasty is a safe and effective method for TM closure in children with reduced surgical time, as compared to PTF.

Molecular resonance tonsillectomy in children: comparative study over standard techniques in an 11-year study.

OBJECTIVES: Learn the molecular resonance (MR) technology for tonsillectomy. An analysis of outcomes of MR compared to standard cold-knife (CK) and monopolar cautery (MPC) for pediatric tonsillectomy offers new possibilities, lowering postoperative morbidity. STUDY DESIGN: Eleven-year, prospective, randomized, 3-group trial. SETTING: Tertiary care pediatric institution. SUBJECTS AND METHODS: Eight hundred and seventy-three children undergoing adenotonsillectomy were randomly assigned to MR (n = 283), CK (n = 279), or MPC (n = 279) techniques. Outcome measures included intraoperative time, blood loss, postoperative pain, weight loss, and histopathologic examination on excised tonsils. RESULTS: Histopathologic evaluation revealed reduced thermal injury with MR over MPC (43 µm vs 186, P < .001), statistically associated with reduced muscular, blood vessel, and nerve fiber damage compared to CK (P < .001). Blood loss was minimal in MR. Significant reduced pain scores were related to MR (P < .002). Two MR, 15 CK, and 12 MPC patients experienced delayed bleeding. CONCLUSION: MR for pediatric tonsillectomy resulted in reduced histopathologic thermal injury, lower pain scores, and reduced postoperative morbidity compared with CK and MPC techniques in an 11-year study.

Stability of osseointegrated bone conduction systems in children: a pilot study.

OBJECTIVES: To obtain objective data of bone conduction implant stability and osseointegration in children; to compare in pediatric subjects the stability and osseointegration of the novel TiOblast-coated implant system (BI300) to the previous generation, as-machined model. STUDY DESIGN: Multicenter, controlled, nonrandomized, longitudinal, prospective study. SETTING: Tertiary referral center. LEVEL OF EVIDENCE: IIIb PATIENTS: Ten subjects were enrolled, aged younger than 16 years and without comorbidities that negatively affect osseointegration. All patients were implanted "single stage": 5 received the previous generation, pure titanium fixture (control group), and 5 were implanted the BI300, TiOblast-coated fixture (test group). INTERVENTIONS: Measurement of implant stability and osseointegration. MAIN OUTCOME MEASURE(S): Implant stability and osseointegration as measured by means of resonance frequency analysis intraoperatively, at 1 week, 2 weeks, 1 month, and every month till processor loading 6 months after surgery. RESULTS: BI300 is, on average, more stable than the control fixture, both intraoperatively and over time till processor loading. Over the 6 months' follow-up, a stability increase was observed with both models, although it resulted statistically not significant. CONCLUSION: The BI300 implant system has a greater primary stability as compared with the previous generation model, but its faster osseointegration could not be definitely verified. It is reasonable to assume that the BI300 fixture will enable surgeons to perform single-stage surgery more safely and with a lower failure rate. The possibility of an earlier processor loading remains to be confirmed in a greater sample.

The new Baha implant: a prospective osseointegration study.

OBJECTIVES: To assess stability of a new-design titanium implant (Cochlear Baha BAI300) in bone-anchored hearing aid (Baha) recipients over time. STUDY DESIGN AND SETTING: Prospective case series with planned data collection at a tertiary care institution. Twelve patients who underwent Baha surgery over 12 months were analyzed. SUBJECTS: All patients (3 children, age range 6-10 years, mean 7.7 years, median 7.3 years; 9 adults, age range 34-73 years, mean 52.8 years, median 48 years) underwent the 1-stage procedure following the standard Brånemark technique. In all procedures, the single-skin incision was applied. METHODS: The stability of the implant was measured with implant stability quotient (ISQ) measurement tests. All patients were tested at surgery and every week after for 1 year. Wound-healing time, degree of soft tissue reactions around the abutment, and need for revision surgery were examined. Two-tailed Student t test and χ(2) for all comparisons were calculated; P < .05 values were considered significant. RESULTS: The new implant showed a steep increase of ISQ values over the first 2 weeks and reached stable ISQ values 3 weeks after surgery. Complete skin healing time was obtained in 8 days on average (range, 7-12 days; median 7.6 days). Neither implant extrusion nor skin revision surgery was observed in our patients during the first year of follow-up. CONCLUSIONS: This new implant revealed stability and fast integration. The data from the present study suggest the new implant may be suitable for early loading protocols.

Tonsillectomy in children: a five-factor analysis among three techniques--reporting upon clinical results, anesthesia time, surgery time, bleeding, and cost.

OBJECTIVES: Improved technology claims better clinical results for adenotonsillectomy (T&A) in children, and promoters of each technique announce many virtues over one another, year after year. However, cost remains one variable that is not always thoroughly addressed. In this study, monopolar cautery (MPC) T&A was compared with coblation (CAT) and molecular resonance (MR) techniques in a pediatric population. STUDY DESIGN: Prospective analysis of 96 patients (32 for each surgical modality: MPC, MR, or CAT). SETTING: Tertiary care pediatric institution. SUBJECTS AND METHODS: Clinical results, anesthesia and surgery time, bleeding, and cost among these three established techniques were compared. P-values of P < .05 were considered significant for all comparisons. RESULTS: The CAT and MPC had similar operative times (mean 19.2 and 21.1 minutes, respectively, P = NS), whereas the MR group had overall saving of 7.8 minutes in surgery (P < .05). In terms of cost of technology, the cost of the MPC and MR groups was 90.6% and 83.7% less than the CAT group, respectively. CONCLUSIONS: This study demonstrated that MR technique of T&A enabled the surgical team to save a significant amount of time, whereas CAT added substantial costs, compared to MR and standard cautery techniques.

TriVerse versus molecular resonance-harvested grafts in single-stage Baha surgery.

OBJECTIVES: To assess complications occurring in patients with a bone-anchored cochlear stimulator (Baha) following split-thickness skin graft harvested with two surgical modalities: the TriVerse (TV) system and the molecular resonance generator (MR). STUDY DESIGN: Prospective, randomized, two-group (TV and MR) study of 24 patients who underwent Baha surgery. SETTING: Tertiary care institution. SUBJECTS AND METHODS: All patients (5 children, age range 6-14 yrs, median 8.3 yrs, and 16 adults, age range 30-73 yrs, median 60 yrs) underwent the one-stage procedure. The skin flap was harvested by use of the TV in 12 cases (2 children, 10 adults) and the MR generator in 12 (3 children, 9 adults). The main outcome measures were wound healing time, number of follow-up visits, degree of soft tissue reactions around the abutment, and need for revision surgery were examined. RESULTS: There was a clear difference between the TV- and MR-harvested skin graft groups in relation to severity of skin reactions and complete healing time. The TV group required from three to seven (median 4) visits as outpatients during the initial observation period until healing was complete. The MR group required only one to three (median 2) visits. Complete healing time was significantly lower in the MR group (range 7-12 days, median 10 days) compared to the TV group (range 15-28 days, median 16 days). In the TV group, two patients required in-office revision of the skin graft because of partial necrosis. CONCLUSIONS: In our experience, the MR-harvested split-thickness skin graft is superior to the TV technique.

Anterior tab flap versus standard underlay myringoplasty in children.

OBJECTIVES: Tympanic membrane (TM) perforation closure can present a problem in children, especially in anterior and total perforations, because of the anterior's lack of support for the graft. It was suggested that the anterior tab flap (ATF) myringoplasty, an underlay graft with an anterior tab under the TM annulus, could provide better stability of the graft. We undertook a prospective, randomized, controlled study to compare the ATF myringoplasty with the standard underlay (SU) myringoplasty in children. METHODS: We randomly assigned 59 children to undergo ATF myringoplasty and 52 to undergo SU myringoplasty at a tertiary care pediatric institution. Surgery was performed under general anesthesia in all patients. The primary outcome was the healing of the TM; the secondary outcomes were anterior blunting of the graft and presence of retraction of the TM. Two years of follow-up were obtained in all enrolled children. RESULTS: At 2 years of follow-up, there were 55 stable TM closures in the ATF arm and 44 in the SU arm. Although the TM closure was higher in the ATF arm than in the SU arm (93.2 and 84.6%, respectively), the results were not statistically significant (odds ratio = 0.4, 95% confidence interval = 0.12-1.41). Anterior blunting and TM retraction were not encountered. CONCLUSION: The ATF myringoplasty is a safe and effective method for TM closure in children. However, compared with the SU myringoplasty, the ATF myringoplasty is not associated with an overall decrease in the incidence of the residual perforations. Further assessment in a larger study is proposed.

Molecular resonance vs. coblation tonsillectomy in children.

BACKGROUND: Quantum molecular resonance coagulation is an innovative technology that uses molecular resonance to cut and coagulate precisely, cleanly, and hemostatically at low tissue temperature levels. This technology offers a new possibility for tonsillectomy. OBJECTIVES: To compare molecular resonance (MRT) with coblation (CAT) devices for pediatric tonsillectomy. STUDY DESIGN: Prospective, two-group, randomized trial in a tertiary care pediatric institution. One hundred fifty-seven children for whom tonsillectomy was indicated were randomly assigned to receive MRT (n = 79) or CAT (n = 78). Main outcome measures included intraoperative time, blood loss, postoperative pain, and weight loss. Histopathologic examination was performed on all excised tonsils. Patients, parents, and pathologist were blinded to surgical modality. RESULTS: Histopathologic evaluation revealed significantly reduced thermal injury with MRT than with CAT (43 microns vs. 126, respectively, P < .001), and was statistically associated with reduced muscular, blood vessel, and nerve fiber damage. No intraoperative blood loss was observed in patients following MRT. Statistically significant reduced pain scores were related to the MRT (P < .002). In addition, the MRT method showed a quick return to normal diet with even weight gain during the 10-day postoperative period. One child in the CAT group experienced delayed bleeding and required readmission. CONCLUSIONS: Molecular resonance for pediatric tonsillectomy resulted in significantly reduced histopathologic thermal injury and lower pain scores compared with coblation. Further studies are advised to support these data.

Contact-diode laser repair of bony choanal atresia: a preliminary report.

OBJECTIVES: To demonstrate the use of the contact-diode laser (CDL) at 810 nm wavelength for the transnasal endoscopic repair of bilateral bony choanal (BBCA) in low-weight newborns. METHODS: Prospective study at a tertiary-care pediatric institution of four neonates with BBCA aged 3-5 days, weighing on average 2.34 kg. BBCA was opened by transnasal delivery of CDL through a 600 microm diameter glass fiber. Children were stented post-operatively, and revision surgery performed when needed. RESULTS: All children were successfully treated for BBCA with CDL. Two children needed only one surgery, one child needed two surgeries, and one patient required three procedures, in order to establish patient choanae at last follow-up ranging from 16 to 30 months. CONCLUSION: We found the fiber-delivered contact-diode laser to permit correction of BBCA in four low-birth weight neonates. To the best of our knowledge, this report is the first to demonstrate the successful use of CDL for the management of BBCA.

Contact diode laser myringotomy for medium-duration middle ear ventilation in children.

OBJECTIVE: To prospectively compare contact diode laser for myringotomy (CDLM) to myringotomy with tube insertion (M&T) for the surgical management of otitis media with effusion (OME) in children. STUDY DESIGN AND SETTING: Prospective randomized controlled study at a tertiary care pediatric institution. METHODS: Thirty children for whom PE tube insertion was indicated were randomized for treatment by CDLM or by M&T, in order to investigate length of time for middle ear ventilation, and complication rates. Surgical time was measured, post-operative parental questionnaires were reviewed, and follow-up examinations were performed. INTERVENTION: Middle ear ventilation by CDLM or M&T. RESULTS: Middle ear ventilation by CDLM took an average of 4.1min, and was maintained for an average of 3.5 months, compared to surgical time of 10.2min for M&T, and duration of middle ear ventilation of 6.3 months. These differences were statistically significant (p=0.005 for surgical time, and p<0.001 for duration of ventilation). Complication rates were equivalent. CONCLUSION: CDLM allowed for medium-duration middle ear ventilation in children compared to M&T. Further study to clarify the role of CDLM in the management of OME in children is indicated.

Tympanic membrane healing process and biocompatibility of an innovative absorbable ventilation tube.

OBJECTIVE: To investigate tympanic membrane healing process and biocompatibility of pressure-equalizing (PE) tubes, made of a novel biodegradable, absorbable material, in an animal model. BACKGROUND: Myringotomy and pressure-equalizing tube insertion is a frequent otologic procedure in children. However, results may vary because of the unpredictable extrusion rate of tubes. Furthermore, tubes that are no longer required need a surgical procedure to be removed. The ideal pressure-equalizing tube should remain in place for the time selected by the otologist, with no need for subsequent removal. This objective could be met with pressure-equalizing tubes made from a self-disintegrating material. METHODS: Pressure-equalizing tubes, made of poly-bis(ethylalanate)phosphazene, were inserted in 55 ears of 28 Hartley guinea pigs, with survival times of 10, 30, and 60 days after tube insertion. In vivo reactions between the poly-bis(ethylalanate)phosphazene pressure-equalizing tubes and the tympanic membrane were studied. Tympanic membranes, middle ears, and tubes were examined by scanning electron microscopy. RESULTS: There was neither infection nor inflammatory reaction to the tube in any animal. The healing process of tympanic membranes revealed neither residual perforation nor inward spread of skin epithelium into the middle ear cavity. At 30 days, 53% of the tubes had disintegrated. At 60 days, tubes were functioning in 25% of ears. CONCLUSION: These new poly-bis(ethylalanate)phosphazene pressure-equalizing tubes are promising. The healing process of tympanic membranes is excellent, with no complications. The tube disintegration rate can be controlled by varying the formulation of the polymer, obtaining tubes with predictable resorption rates, to adapt treatment to the needs of each single patient.

Contact diode laser tonsillectomy in children.

OBJECTIVE: To compare contact diode laser (CDL) tonsillectomy to monopolar cautery (MPC) with regard to pain and other morbidity during recovery. STUDY DESIGN AND SETTING: Single-blind, randomized trial in a tertiary-care pediatric hospital. Tonsillectomy was performed by CDL in 30 children and by MPC in 28. Parents completed a daily questionnaire for 10 days after surgery. RESULTS: There was significantly less pain in the CDL group than in the MPC group. The CDL group also required much less medication, and was much less likely to experience multiple awakenings (P < 0.001 for all comparisons). CONCLUSION: Recovery after CDL tonsillectomy was associated with much less pain and discomfort than after MPC surgery. SIGNIFICANCE: Postoperative pain is a major concern for surgeons, patients, and their parents. The long recovery period also has costs in school days missed for the child and work missed for the parents. CDL tonsillectomy may greatly mitigate these burdens.

Contact diode laser myringotomy and mitomycin C in children.

OBJECTIVE: To investigate the use of contact diode laser myringotomy (C-LAM), combined with topical mitomycin C, as an alternative method for prolonged middle ear ventilation in children with otitis media with effusion. STUDY DESIGN AND SETTING: Prospective study at a tertiary care pediatric institution. METHODS: Fifteen children enrolled in the study. Mitomycin C was applied to the intact tympanic membrane in the right ears, whereas saline on the left side was used for controls. C-LAM was then performed in all ears. Outcome measures included healing rate and scarring, ear infection, and long-term audiometric follow-up. RESULTS: There was no significant difference in median healing rate. In each group, the median was between the third and fourth month. Normal hearing thresholds were obtained in all children at 2-year follow-up. CONCLUSION: C-LAM proved to be an effective method for medium-term ventilation, but topical mitomycin C before C-LAM did not prolong patency rate in our patients. No significant complication was encountered at 2-year follow-up.

A new absorbable pressure-equalizing tube.

OBJECTIVE: We investigated pressure-equalizing (PE) tubes made of biodegradable, absorbable material in an animal model. METHODS: PE tubes, made of poly-bis(ethylanate)phosphazene (PBE) were inserted in 55 ears of 28 Hartley guinea pigs, with survival times of 10, 30, and 60 days after tube insertion. In vivo reactions between the PBE-PE tube and the tympanic membrane (TM) were studied. Tubes, TMs, and middle ears were examined by scanning electron microscopy and light microscopy. RESULTS: There was neither infection nor an inflammatory reaction to the tube within the middle ear in any animal. At 30 days, 53% of the tubes had disintegrated. At 60 days, tubes were still functioning in the 25% of ears. CONCLUSION: More research must be performed before these new PBE PE tubes can be considered for clinical use. Nonetheless, these tubes are promising. The disintegration rate can be controlled by varying the formulation of the polymer, so treatment can be adjusted to the needs of each patient.