The relationship between the Ottawa Valve Collapse Scale (OVCS) and clinical outcomes in septoplasty patients.

The Ottawa Valve Collapse scale (OVCS) was developed to classify the severity of nasal valve collapse (NVC) in patients with nasal obstruction. The goal of this study was to determine, in patients who have nasal obstruction due to a septal deviation, whether those with a higher OVCS grade will have a reduced improvement in patient-centered clinical outcomes at one-year following septoplasty with inferior turbinate diathermy compared to those with a normal or lower OVCS grade. This study was a prospective study of 78 patients who completed an assessment using the NOSE questionnaire before and at one-year following the surgical intervention. A repeated-measures ANOVA was used to asses for differences in scores between OVCS groups. There was a significant improvement in NOSE scores one year post-septoplasty (p < 0.01). There was no difference in NOSE score improvement when comparing the grades of the OVCS at one-year (F = 0.09, p = 0.968). Though the OVCS was designed to categorize the severity of NVC preoperatively, there is no evidence that it is helpful in predicting which patients will demonstrate poor results following septoplasty. Future studies are required to further evaluate the OVCS and whether complimentary assessments will improve its clinical utility.

Diagnosis and management of septal deviation and nasal valve collapse - a survey of Canadian otolaryngologists.

BACKGROUND: Management of nasal valve collapse (NVC) in patients with a septal deviation can be challenging. Our objective was to determine the opinions of Canadian Otolaryngologists regarding the diagnosis and management of nasal obstruction in patients with septal deviation and NVC. METHODS: A twenty-question survey was developed for the purpose of our study. Questions were divided into the following areas: diagnosis, management and prognosis. We included all otolaryngologists who were members of the Canadian Society of Otolaryngology. RESULTS: The response rate to our survey was 18%. The most commonly identified cause of a failed septoplasty was incomplete septoplasty (41.9%), followed by nasal valve collapse (25.6%). The Cottle manoeuvre (62.8%) and visual inspection (39.5%) were noted to be the most important diagnostic tools for external and internal NVC respectively. However, physicians often rely on a variable number of different examinations when making a diagnosis of nasal valve collapse. When evaluating which patients with a septal deviation also required nasal valve surgery, 27.9% of responders believed the current physical examination methods provided a high accuracy, while 55.8% indicated moderate accuracy and 16.3% indicated low accuracy. Compared to other subspecialties in Otolaryngology, Facial Plastic and Reconstruction Surgeons noted higher septoplasty failure rates in patients with co-morbid NVC. CONCLUSIONS: NVC is an important concern for otolaryngologists performing septoplasty. Although most physicians believe that the physical exam provides a moderate effectiveness when predicting who requires a functional rhinoplasty, diagnostic methods used for NVC is varied and inconsistent.

A systematic review and network meta-analysis of existing pharmacologic therapies in patients with idiopathic sudden sensorineural hearing loss.

BACKGROUND: Hearing loss is one of the leading causes of disability worldwide. Patients with hearing loss experience impaired quality of life, as well as emotional and financial consequences that affect both themselves and their families. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common but difficult to treat condition that has a sudden onset of ≤ 72 hour associated with various etiologies, with the majority of cases being idiopathic. There exists a wide range of therapeutic options, however, the uncertainty surrounding their comparative efficacy and safety makes selection of treatment difficult. This systematic review and network meta-analysis (NMA) assessed the relative effects of competing treatments for management of ISSNHL. METHODS: A protocol for this review was registered with PROSPERO (CRD42017073756). A detailed search of MEDLINE, Embase and the Cochrane Library from inception to February 8th, 2018 was carried out by an experienced information specialist. Grey literature was also searched. Screening full-text records, and risk of bias assessment were carried out independently by two reviewers, and disagreements were resolved through consensus or third party adjudication, while data was collected by one reviewer and verified by a second reviewer. Bayesian network meta-analyses (NMA) were performed to inform comparisons between interventions for a priori specified outcomes that included pure tone average (PTA) improvement and hearing recovery. RESULTS: The search identified a total of 1,138 citations, of which 613 remained for review after removal of duplicates. Of these, 23 publications describing 19 unique studies (total sample size of 1,527) met our a priori eligibility criteria, that were assessed to be at unclear or high risk of bias on several domains. We identified data on several interventions for ISSNHL therapy and were able to construct treatment networks consisting of six intervention groups that included placebo; intratympanic (IT) steroid; IT plus systemic steroid; per oral (PO) steroid; intravenous (IV) steroid; and IV plus PO steroid for our NMAs. IT plus systemic steroids demonstrated the largest difference in PTA improvement compared to placebo (25.85 dB, 95% CrI 7.18-40.58), followed by IV plus PO steroids (22.06 dB, 95% CrI 1.24-39.17), IT steroids (18.24 dB, 95% CrI 3.00-29.81). We observed that the difference of PTA improvement between each intervention and placebo diminished over time, attributed to spontaneous recovery. The binary outcomes of hearing recovery demonstrated similar relative ordering of interventions but were less sensitive than PTA improvement to capture the significant differences between interventions and placebo. CONCLUSION: Unclear to high risk of bias trials rated IT plus systemic steroid treatment as the best among the six interventions compared, and all active treatments were better than placebo in improving PTA. However, it should be noted that certain comparisons were based on indirect evidence only or few studies of small sample size, and analyses were unable to control for steroid type and dosage. Given these limitations, further data originating from methodologically sound and rigorous trials with adequate reporting are needed to confirm our findings.

Assessment of Pliability and Elasticity of the External Nasal Skin in Patients With Unilateral Nasal Valve Collapse: A Static Biomechanical Evaluation.

IMPORTANCE: Understanding the skin biomechanics, specifically pliability and elasticity, in patients with nasal valve collapse may allow for new methods to assess which patients require more advanced nasal valve surgery. OBJECTIVE: To test the hypothesis that in patients with unilateral nasal valve collapse, the side of the nose with the collapse will have lower elasticity and increased pliability compared with the normal side, as assessed by a blinded observer using the Cutometer MPA 580. DESIGN, SETTING, AND PARTICIPANTS: Prospective, investigator-blinded, case-control cohort study of patients with unilateral nasal valve collapse and subjective nasal obstruction conducted in an academic otolaryngology-head and neck surgery clinic. INTERVENTIONS: Patients were assessed using the Cutometer MPA 580 by a blinded assessor. Three measurements were performed bilaterally on the exterior skin of the nose corresponding to the level of the inferior edge of the upper lateral cartilage. Measurements taken at the skin inferior to the zygoma were used as a control. MAIN OUTCOMES AND MEASURES: Primary outcome measures of the nasal skin were pliability (Uf, defined as the lengthening of the skin after 3 seconds of constant load) and elasticity (Ua/Uf, defined as the percentage of the skin that returned to its normal position 3 seconds after the release from the 3-second constant load). RESULTS: Of the 27 patients included in the study, 15 (56%) were male, and 12 (44%) were female; mean (SD) age, 44 (21) years (range, 16-90 years). There was no difference between the measurements of the skin overlying the area of nasal valve collapse in elasticity: side without collapse (0.960% [0.031%]) vs side with collapse (0.967% [0.036%]) (mean difference, 0.007%; 95% CI, -0.018% to 0.021%) (P = .90). However, there was a significant difference in pliability: side of the nose without collapse (0.520 [0.139] mm) vs side with collapse (0.610 [0.200]) (mean difference, 0.090 mm; 95% CI, 0.014-0.156 mm) (P = .02). CONCLUSIONS AND RELEVANCE: Although the skin in patients with nasal valve collapse appears to maintain its elasticity, it demonstrates an increased ability to stretch and lengthen compared with nasal skin of those without valve collapse. Future studies are required to determine whether the biomechanical changes are related to the length and severity of nasal obstruction, or whether these changes in the skin may help predict who will benefit from nasal valve surgery and whether these patients are at an increased risk of surgical failure. LEVEL OF EVIDENCE: 2.

A prospective cohort study assessing the clinical utility of the Cottle maneuver in nasal septal surgery.

BACKGROUND: A nasal septal deviation can have a significant detrimental effect on a patient's quality of life. Nasal valve collapse (NVC) often co-exists with a septal deviation. The Cottle maneuver is one of the most common methods to diagnose NVC; however, no study has assessed the efficacy of this physical exam finding. This study tests the hypothesis that patients with nasal obstruction due to a septal deviation with a negative pre-operative Cottle maneuver will demonstrate a greater improvement in their Nasal Obstruction Symptom Evaluation (NOSE) score, compared to patients who demonstrate a positive pre-operative Cottle maneuver, when assessed at 12 months following a septoplasty with turbinate diathermy. METHODS: This was a prospective Cohort Study. The population was 141 patients with nasal obstruction due to a septal deviation with or without nasal valve collapse, excluding patients with bilateral complete nasal valve collapse. Patients were placed in cohorts according to the results of the Cottle maneuver (positive or negative). A NOSE questionnaire was administered at baseline and 12-months after a septoplasty with turbinate diathermy. Non-adjusted NOSE scores were used (score out of 20). An ANOVA was used to compare if there was a difference in outcomes between patient cohorts. RESULTS: One hundred and forty-one patients completed 12-month follow-up with 71.5% of patients demonstrating a positive Cottle maneuver at baseline. The mean (95% C.I.) difference in NOSE score at 12 months between patients with a positive Cottle versus a negative Cottle was 0.18 (- 1.6 to 1.92; p = 0.38). CONCLUSION: In a univariate, single surgeon study, a positive Cottle Maneuver does not appear to influence outcomes in the described patient population compared to those with a negative Cottle Maneuver when undergoing a septoplasty.

Reliability and construct validity of the Ottawa valve collapse scale when assessing external nasal valve collapse.

BACKGROUND: Nasal valve collapse is a common cause of nasal obstruction in otolaryngology practice. Common examination methods, such as the Cottle Maneuver and modified Cottle Maneuver are available. However, these methods are dichotomous and do not provide ordinal severity information. The Ottawa Valve Collapse Scale (OVCS) is a grading system for assessing and easily grading external nasal valve collapse in patients with a septal deviation. The primary objective was to assess the test-retest reliability and construct validity of the OVCS grading scale. A secondary objective was to perform the same assessments on the Cottle Maneuver. METHODS: Patients with a septal deviation who were requesting surgical correction were prospectively enrolled in the study. All patients were assessed using both the Cottle Maneuver and the OVCS by one otolaryngologist at two visits separated by one month. The phi coefficient was calculated to assess the test-retest reliability of the instruments. Results of the Nasal Obstruction Symptom Evaluation (NOSE) Score was compared to determine construct validity. RESULTS: Ninety-two patients met our inclusion criteria. The phi coefficient was 0.62 for the OVCS and 0.32 for the Cottle Maneuver. The scores on the NOSE instrument were positively associated with the OVCS scores (p = 0.01) while there was no association with the Cottle Maneuver (p = 047). CONCLUSION: This current preliminary analysis suggests that the novel Ottawa Valve Collapse Scale has good test-retest reliability and construct validity. This scale may help clinicians grade external nasal valve collapse in patients with a septal deviation. Future studies are required to determine if this scale assists surgeons in determining which patients need formal nasal valve surgery in addition to a standard septoplasty.

Autoantibodies in Melanoma-Associated Retinopathy Recognize an Epitope Conserved Between TRPM1 and TRPM3.

Purpose: Melanoma-associated retinopathy (MAR) is a paraneoplastic syndrome associated with malignant melanoma and the presence of anti-retinal autoantibodies, including autoantibodies against transient receptor potential melanopsin 1 (TRPM1), a cation channel expressed by both melanocytes and retinal bipolar cells. The goal of this study was to further map the antigenic epitope. Methods: Patient sera were tested by immunofluorescence and Western blotting on HEK293 cells transfected with enhanced green fluorescent protein (EGFP)-TRPM1 fusion constructs and mouse retina sections. Results: The epitope recognized by MAR patient sera was mapped to a region encoded by exons 9 and 10 of the human TRPM1 gene. This region of TRPM1 is highly conserved with TRPM3, and indeed MAR sera were found to cross-react with TRPM3, a closely related channel expressed in the retinal pigment epithelium (RPE). Conclusions: These results indicate that TRPM1 autoantibodies in MAR patient sera recognize a short, intracellular segment of TRPM1. Cross-reactivity with TRPM3 in the RPE may account for other visual symptoms that are experienced by some MAR patients such as retinal and RPE detachments. We propose that TRPM1 autoantibodies are generated in response to abnormal TRPM1 polypeptides encoded by an alternate mRNA splice variant expressed by malignant melanocytes.

Determining a Successful Nasal Airway Surgery: Calculation of the Patient-Centered Minimum Important Difference.

Objective Determine whether the patient-identified minimum important difference (MID) in Nasal Obstruction Symptom Evaluation (NOSE) score differs from a statistically calculated estimate of MID in patients with septal deviation undergoing nasal airway surgery. Study Design Prospective cohort. Setting Tertiary academic referral center. Subjects Patients with nasal obstruction due to septal deviation. Methods Patients completed the NOSE questionnaire preoperatively and indicated the change from their baseline score that they would consider the minimum improvement required to define the septoplasty with turbinate reduction as successful. A previously published distribution-based approach was used to estimate the MID based on baseline NOSE scores. Scores were reported both as a raw score and as a percentage of patients' baseline scores. One-sample t test was used to compare the statistically estimated MID to the patient-reported MID. Results Seventy-six patients were included. The mean (SD) baseline NOSE score was 12.9 (4.03). The mean (SD) patient-identified MID was 5.3 (2.1), corresponding to a 41.1% change (95% confidence interval, 37.2-41.3) from baseline. The statistically estimated MID was 5.2 points (40.3% reduction from baseline scores). The estimated MID was not significantly different from the patient-identified MID ( P = .4). Conclusion In patients with septal deviation, an improvement of approximately 40% in their nasal obstructive symptoms as assessed by the NOSE questionnaire is required to define a nasal airway surgery as successful. The patient-identified and the statistically calculated MIDs were similar. Furthermore, this MID can be used to guide research, improving the ability to use the NOSE score as a dichotomous scoring measure (treatment success/failure) and estimating sample size.

The Role of Helicobacter pylori in Laryngopharyngeal Reflux.

Objective The primary objective was to determine the prevalence of Helicobacter pylori among patients with laryngopharyngeal reflux. The secondary objective was determining if H pylori eradication leads to greater symptom improvement in patients with laryngopharyngeal reflux as compared with standard proton pump inhibitor therapy alone. Data Sources EMBASE, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, World Health Organization International Clinical Trials Registry Platform, European Union Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov. Review Methods A systematic review was performed of studies assessing the diagnosis or treatment of H pylori among patients with laryngopharyngeal reflux. Randomized controlled trials, cohort studies, case-control studies, and case series were included. A meta-analysis of prevalence data and assessment of heterogeneity was performed on relevant studies. Results Fourteen studies were analyzed in the review, with 13 eligible for the meta-analysis. We determined that the prevalence of H pylori among patients with laryngopharyngeal reflux was 43.9% (95% confidence interval, 32.1-56.5). The heterogeneity of studies was high, with an overall I2 value of 92.3%. We were unable to quantitatively assess findings for our secondary outcome, since H pylori identification and treatment were not the primary focus of the majority of studies. Conclusion There is a high rate of H pylori infection among patients with laryngopharyngeal reflux. The infection rate in North America and Western Europe has not been adequately studied. There is insufficient evidence to make a recommendation regarding the testing and treatment of H pylori infection among patients with laryngopharyngeal reflux.

A Comparative Assessment of Three Formulations of Botulinum Toxin Type A for Facial Rhytides: A Systematic Review with Meta-Analyses.

BACKGROUND: Three formulations of botulinum toxin are available for facial rhytides. It is unclear which formulation offers the greatest balance of benefits and harms. The objective of this study was to conduct a systematic review with meta-analyses to compare formulations of botulinum toxin for reduction of facial rhytides at the glabella. METHODS: The authors' protocol was registered with the International Prospective Register of Systematic Reviews (CRD4201200377). A systematic literature search was performed identifying double-blind studies. The authors assessed 1-, 3-, and 4-month follow-up. The authors performed pairwise meta-analyses using random effects models to compare response rates among the three botulinum formulations and a network meta-analysis. RESULTS: A total of 18 studies (3082 patients) were included. At 30-, 90-, and 120-day follow-up, all medications with available data showed statistically significantly increased treatment response versus placebo. Only high-dose onabotulinum toxin (compared to standard-dose onabotulinum toxin) offered additional benefit at 30 days. Exploratory analysis using network meta-analysis mostly suggested insufficient evidence of incremental benefits when comparing specific formulations. CONCLUSIONS: Evidence supporting benefits versus placebo of the different formulations was clear over time. Comparisons between active formulations were rare and typically based on single trials of small to moderate sample size. The data suggest some gains with high-dose onabotulinum toxin (relative to standard dose), whereas exploratory indirect comparisons between active formulations were largely associated with inconclusive findings. Future studies should undertake head-to-head comparisons of the different formulations and ensure longer follow-up to best inform the accumulating evidence base. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A comparison of Locacorten-Vioform and clotrimazole in otomycosis: A systematic review and one-way meta-analysis.

OBJECTIVES/HYPOTHESIS: The goal of this systematic review was to compare the efficacy and ototoxicity of Locacorten-Vioform (Paladin Labs Inc., Montreal, Quebec, Canada) and clotrimazole in the treatment of patients with otomycosis. DATA SOURCES: Embase, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, World Health Organization International Clinical Trials Registry Platform, European Union Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov. METHODS: We included any randomized controlled trials or nonrandomized studies (case-control, cohort, and case series) assessing the topical use of Locacorten-Vioform (Paladin Labs Inc.) and/or clotrimazole in adult and/or pediatric immunocompetent patient population with otomycosis. DerSimonian and Laird's random effects approach was used for meta-analysis, followed by an assessment of heterogeneity and subgroup analysis. RESULTS: Of 226 reviewed articles, 14 were retained. Clotrimazole efficacy rate was 85% (95% confidence interval [CI]: 79.7-89.0%), whereas Locacorten-Vioform (Paladin Labs Inc.) was 73% (95% CI: 56.0-84.5%). Overall, study quality was low. There was high heterogeneity in both groups (I(2) of 47 and 49). There were only three studies assessing Locacorten-Vioform (Paladin Labs Inc.); therefore, comparative assessment was not possible. A one-way meta-analysis involving 13 clotrimazole studies was performed. Heterogeneity across studies was high; however, studies using objective analysis assessing treatment efficacy, randomized controlled trials, studies using drops, studies performed in Asia, and studies where Candida was the major fungus at diagnosis demonstrated low heterogeneity. CONCLUSION: Although both are safe and effective, there is insufficient evidence supporting increased efficacy of either clotrimazole or Locacorten-Vioform (Paladin Labs Inc.) for the treatment of otomycosis. High-quality comparative studies are required. LEVEL OF EVIDENCE: N/A. Laryngoscope, 126:1411-1419, 2016.

Anti-IgE monoclonal antibody therapy for the treatment of chronic rhinosinusitis: a systematic review.

BACKGROUND: Several options are available for the treatment of chronic rhinosinusitis (CRS), but disease control remains elusive for many patients. Recently, literature has emerged describing anti-IgE monoclonal antibody as a potential therapy for CRS. However, its effectiveness and safety are not well known. The purpose of this systematic review was to assess the effectiveness and safety of anti-IgE therapy and to identify evidence gaps that will guide future research for the management of CRS. METHODS: Methodology was registered with PROSPERO (No. CRD42014007600). A comprehensive search was performed of standard bibliographic databases, Google Scholar, and clinical trials registries. Only randomized controlled trials assessing anti-IgE therapy in adult patients for the treatment of CRS were included. Two independent reviewers extracted data using a pre-defined extraction form and performed quality assessment using the Cochrane risk of bias tool and the GRADE framework. RESULTS: Two studies met our inclusion criteria. When comparing anti-IgE therapy to placebo, there was a significant difference in Lund-McKay score (p = 0.04) while no difference was seen for percent opacification on computed tomography (CT). At 16 weeks, treatment led to a decrease in clinical polyp score. No significant difference was seen with regard to quality of life (Total Nasal Symptom Severity (TNSS), p < 0.21; Sinonasal Outcome Test 20 (SNOT-20), p < 0.60), and no serious complications were reported in either trial. Based on the quality assessment, studies were deemed to be of moderate risk of bias and a low overall quality of evidence. CONCLUSIONS: There is currently insufficient evidence to determine the effectiveness of anti-IgE monoclonal antibody therapy for the treatment of CRS.

Alterations in the Elasticity, Pliability, and Viscoelastic Properties of Facial Skin After Injection of Onabotulinum Toxin A.

IMPORTANCE: This prospective cohort study provides evidence and information on the mechanism of action of onabotulinum toxin A on the reduction of skin elasticity and pliability. Understanding the natural course that onabotulinum toxin A has on the elasticity of skin may help physicians understand why there appears to be a progressive reduction in wrinkle levels with repeated treatments. OBJECTIVE: To determine whether onabotulinum toxin A increases skin pliability and elasticity with a corresponding decrease in the contribution of the viscoelastic component of skin resistance. DESIGN, SETTING, AND PARTICIPANTS: From October 1, 2012, through June 31, 2013, this prospective cohort study enrolled 48 onabotulinum toxin A-naive women (mean [SD] age, 55.2 [11.3] years) with a minimum of mild wrinkle levels at the glabella and lateral orbit (43 completed the study). Patients were treated at a private cosmetic surgery clinic with onabotulinum toxin A and assessed at baseline and 2 weeks, 2 months, 3 months, and 4 months after injection. INTERVENTIONS: Standardized onabotulinum toxin A was administered to patients' glabella, supraorbit, and lateral orbit. MAIN OUTCOMES AND MEASURES: Skin pliability, elastic recoil, and the ratio of viscoelastic resistance (Uv) to elastic resistance (Ue). RESULTS: For the supraorbit, there was a significant effect of time on pliability (F = 20.5), elastic recoil (F = 6.92), and Uv/Ue ratio (F = 5.6) (P < .001 for all). For the glabella, there was a significant effect of time on pliability (F = 32.23), elastic recoil (F = 31.66), and Uv/Ue ratio (F = 10.11) (P < .001 for all). For the lateral orbit, there was a significant effect of time on pliability (F = 15.83, P < .001), elastic recoil (F = 11.43, P < .001), and Uv/Ue ratio (F = 10.60, P = .009). CONCLUSIONS AND RELEVANCE: This study provides further evidence that there is an alteration in biomechanical properties of the skin after injection with onabotulinum toxin A. This effect appears to last up to 4 months in the glabella and up to 3 months at other sites. The decrease in the Uv/Ue ratio suggests onabotulinum toxin A injection does not result in an increase in tissue edema suggestive of an inflammatory reaction within the skin. However, it remains unclear whether this is due to an intrinsic property of the medication or another unrecognized mechanism. LEVEL OF EVIDENCE: 2.

Discomfort during Periorbital and Lateral Temporal Laser Vein Treatment: A Double-blind Randomized Controlled Trial.

BACKGROUND: Treatments for cosmetically unpleasing periocular and lateral temporal veins are limited. The purpose of this study was to test the hypothesis that the application of topical lidocaine before the cosmetic treatment of periorbital and lateral temporal veins with a neodymium-doped yttrium aluminum garnet (ND:YAG) laser will result in a significant reduction in subjective pain compared with placebo as assessed using a visual analogue scale. METHODS: Twenty patients who required bilateral treatment of facial veins were randomly assigned to receive either placebo or 30% lidocaine gel applied topically over the veins, a split-body design. Both the investigator and the patient were blinded to the treatment. An ND:YAG laser was used to treat the veins. Patients completed a visual analogue scale to assess the pain on each side of the face. Data were analyzed using nonparametric data testing. RESULTS: There was a 64.0% reduction in pain on the treatment side compared with the placebo side (P < 0.001). There was no significant difference in patient-assessed subjective efficacy between sides (P = 0.2). Complications were minimal and mild. CONCLUSIONS: Patients undergoing periorbital and temporal vein ablation using ND:YAG laser should be offered topical lidocaine as the pain levels are moderate. The use of topical 30% lidocaine results in a significant reduction in pain levels.

The effect of topically applied tissue expanders on radial forearm skin pliability: a prospective self-controlled study.

BACKGROUND: The use of pre-operatively applied topical tissue expansion tapes have previously demonstrated increased rates of primary closure of radial forearm free flap donor sites. This is associated with a reduced cost of care as well as improved cosmetic appearance of the donor site. Unfortunately, little is known about the biomechanical changes these tapes cause in the forearm skin. This study tested the hypothesis that the use of topically applied tissue expansion tapes will result in an increase in forearm skin pliability in patients undergoing radial forearm free flap surgery. METHODS: Twenty-four patients scheduled for head and neck surgery requiring a radial forearm free flap were enrolled in this prospective self-controlled observational study. DynaClose tissue expansion tapes (registered Canica Design Inc, Almonte, Canada) were applied across the forearm one week pre-operatively. Immediately prior to surgery, the skin pliability of the dorsal and volar forearm sites were measured with the Cutometer MPA 580 (registered Courage-Khazaka Electronic GmbH, Cologne, Germany) on both the treatment and contralateral (control) arms. Paired t-tests were used to compare treatment to control at both sites, with p < 0.025 defined as statistically significant. RESULTS: There was a statistically significant increase in pliability by a mean of 0.05 mm (SD = 0.09 mm) between treatment and control arms on the dorsal site (95% CI [0.01, 0.08], p = 0.018). This corresponded to an 8% increase in pliability. In contrast, the volar site did not show a statistically significant difference between treatment and control (mean difference = 0.04 mm, SD = 0.20 mm, 95% CI [-0.04, 0.12], p = 0.30). CONCLUSIONS: This result provides evidence that the pre-operative application of topical tissue expansion tapes produces measurable changes in skin biomechanical properties. The location of this change on the dorsal forearm is consistent with the method of tape application. While this increase in skin pliability may account for the improved rate of primary donor site closure reported using this technique, the results did not reach our definition of clinical significance.

Skin Biomechanical Changes after Injection of Onabotulinum Toxin A: Prospective Assessment of Elasticity and Pliability.

OBJECTIVE: This study aimed to test the hypothesis that the administration of onabotulinum toxin A will result in an increase in skin pliability and elasticity. STUDY DESIGN: A prospective case series with planned data collection in which patients were treated with onabotulinum toxin and assessed at baseline, 2 weeks post-injection, and 2 months post-injection. SETTING: A private cosmetic surgery clinic associated with a tertiary academic hospital. SUBJECTS AND METHODS: Forty women were prospectively enrolled to receive onabotulinum toxin A into their glabella, forehead, and lateral orbit. Outcomes were assessed at baseline, 2 weeks posttreatment, and 2 months posttreatment using the Cutometer MPA 580. Skin pliability (Uf) and the elastic recoil (Ua/Uf) were recorded as the 2 primary outcome measures. RESULTS: There was a significant effect of onabotulinum toxin on skin elasticity (f = 47.8, P = .001) with a mean (+/- SE) increase in elastic recoil of 20% (4.4%) for the glabellar region (P < .001) and 18% (4.0%) for the lateral orbit (P < .0001). There was a significant effect of the treatment on skin pliability (f = 46.9, P < .001) with a mean (+/- SE) increase of 26% (5.4%) for the lateral orbit (P = .001) and 52% (8.3%) for the glabellar region (P < .001). CONCLUSION: Injection of onabotulinum toxin into the lateral orbital, forehead, and glabellar regions results in skin that has increased pliability as well as increased elastic recoil. Although this study demonstrates the positive effect of onabotulinum toxin on biomechanical parameters, it is unclear what specific histological changes are occurring within the skin.

The effect of probe placement on inter-trial variability when using the Cutometer MPA 580.

There is limited data independently assessing the optimal use of the Cutometer MPA580. The purpose of this study is to test the hypothesis that the assessment of elastic recoil is significantly different when utilizing two different probe placement protocols. In protocol A, four trials were performed, in which the probe was removed from the skin between trials. In protocol B, the probe was not removed from the skin between trials. Fifty-four patients were enrolled and all completed the testing. When assessing elasticity (Ua/Uf), the inter-class correlation was 0.83 for protocol A and 0.48 for protocol B (p <0.001). There was no significant difference between individual trials for protocol A. Trial one of protocol B was significantly different (p < 0.001) than trials 2-4 for protocol B. Trial one of protocol B was not significantly different than any trial in protocol A. The results of this study suggest that the method in which a clinician performs repeated measure testing has a significant effect on the outcome measures when using the Cutometer. Removing the probe between trials appears to result in measures with higher reliability.

Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis.

OBJECTIVES/HYPOTHESIS: To evaluate the effectiveness of gelatin-thrombin matrix for first line treatment of posterior epistaxis. Secondarily, we evaluated discomfort during treatment and the cost savings of treatment with gelatin-thrombin matrix compared to posterior packing, endoscopic, or endovascular treatment at our institution. STUDY DESIGN: Prospective pilot, nonblinded, noncontrolled registered clinical trial (NCT01098578). METHODS: Twenty patients with posterior epistaxis were enrolled into this study. Gelatin-thrombin matrix was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion. Patients were discharged within 2 hours of being successfully treated. A visual analog scale (range 0-10) was used to assess treatment discomfort. Patients were evaluated in clinic 5 and 30 days after treatment to assess for intranasal complications and recurrent epistaxis. RESULTS: Gelatin-thrombin matrix successfully treated epistaxis in 80% of the patients. The procedure was associated with a mean discomfort of 3.6 (range 0-9.7). The institutional per case cost of treatment of patients with posterior epistaxis with gelatin-thrombin matrix is 80.3%, 87.4%, and 89.4% less than with endoscopic surgery, posterior packing, or embolization, respectively. There were no complications. CONCLUSION: This pilot study demonstrated that gelatin-thrombin matrix is a safe and both a clinically effective and cost-saving means of treating posterior epistaxis. In this study, its use is associated with a low level of discomfort. This treatment method may improve the quality of care for patients with posterior epistaxis.

A comparative assessment of three formulations of botulinum toxin A for facial rhytides: a systematic review and meta-analyses.

BACKGROUND: Botulinum toxin A is a commonly used biological medication in the field of facial plastic surgery. Currently, there are three distinct formulations of botulinum toxin A, each with their purported benefits and advantages. However, there is considerable confusion as to the relative efficacy and side-effects associated with each formulation. Therefore, the purpose of this paper is to systematically assess published studies and perform a meta-analysis to determine if there is a significant advantage of any of the individual formulations. METHODS/DESIGN: A systematic literature search was performed for all relevant English language randomized controlled trials using Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, World Health Organization (WHO) International Clinical Trials Registry Platform, European Union (EU) Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov. Inclusion criteria included any randomized controlled trial (RCT) that assessed the use of botulinum toxin for cosmetic purposes. The included articles were also analyzed for bias using the Cochrane Collaboration's tool for assessing the risk of bias in RCTs. DISCUSSION: The results of this review will provide clinicians with an unbiased, high level of evidence of the comparative efficacy of individual preparations of botulinum toxin A.

The effect of probe to skin contact force on Cutometer MPA 580 measurements.

The purpose of this study is to test the hypothesis that increasing the force applied on the skin by the Cutometer MP580 probe will result in a decrease in the skin elasticity measures. Specifically, this study assessed the probe intrinsic weight plus the addition of a light mass (10 g and 20 g), a moderate mass (50 g and 100 g) and a high mass (200 g and 500 g) on skin elasticity measures. Primary outcome measures Uv, Ur, Uf, Ue and Ua, along with calculated measures Uv/Uf, Ua/Uf and Ur/Uf were assessed under each loading condition. A general linear model ANOVA with repeated measures was used to assess for differences in each outcome measure between each loading condition. Thirty-two patients were enrolled and all completed the testing. For all primary variables except Uv (p < 0.001), there was no statistically significant effect of adding a light mass to the probe. There was a significant effect of the addition of a moderate and heavy mass for all variables (p < 0.005) except Ue/Uf. These results suggest that the addition of a low mass results in no significant effect on outcome measures. However, if moderate-to-heavy additional force is applied to the probe, the outcome measures are significantly altered. Of all the variables, Ue/Uf appears to be influenced the least by alterations in force. Users should ensure light contact is made between the skin and probe during testing to avoid a false alteration in outcome measures of skin elasticity.