Stratifying risk of malignancy in cystic lateral neck lumps: a multivariant analysis of demographic, radiological and histological investigation factors and the development of a patient-centred risk-predictive tool for malignancy.

BACKGROUND: Management of lateral cystic neck masses with no apparent upper aerodigestive tract primary tumour in adults is controversial. Imaging modalities and fine needle aspiration cytology often struggle to distinguish the presence of malignancy. METHOD: This study entailed a multicentre retrospective review of all patients with isolated lateral cystic neck masses from 2012 to 2018 in three Welsh health boards, utilising demographic data and first-line investigations (ultrasound scanning and fine needle aspiration cytology) to develop an evidence-based predictive tool for risk of malignancy. RESULTS: It was found that 29.1 per cent of cystic lesions were malignant on final histology. Age, male gender, non-benign ultrasound scan findings and fine needle aspiration cytology were significant risk factors on univariate analysis. The final multivariate analysis predicted a risk of malignancy ranging from 2.1 to 65.0 per cent depending on the covariate pattern. Smoking status was non-significant. CONCLUSION: A rigorous, risk-stratified approach to the management of these patients should aid the clinician in minimising morbidity and optimising resources.

Randomized, placebo-controlled evaluation of chlorobutanol, potassium carbonate, and irrigation in cerumen removal.

OBJECTIVES: We evaluated the efficacy over a short period of time of two ceruminolytic products, Otocerum (chlorobutanol, phenol, turpentine essence, ethyl alcohol; Reig Jofre Laboratories, Barcelona, Spain) and Taponoto (potassium carbonate, ethyl alcohol, glycerol, thymol; Teofarma Iberica SA, Barcelona), in adult subjects with complete occlusion of the ear canal due to cerumen. METHODS: Ninety subjects with complete occlusion of the ear canal were enrolled in a randomized, subject- and observer-blinded, placebo-controlled clinical trial. The subjects were randomly assigned to one of three different treatments: Otocerum, Taponoto, or sterile saline solution (control group). The test medication was instilled into an occluded ear for 15 minutes. After this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes completely visualized after treatment. RESULTS: One subject among the 90 enrolled did not accept a second ear irrigation and was excluded from the study. Neither Otocerum nor Taponoto was superior to saline solution. Cerumen occlusion resolved in 21 of 32 subjects treated with Otocerum (65.6%), 16 of 29 treated with Taponoto (55.2%), and 12 of 28 treated with saline solution (42.9%). CONCLUSIONS: The use of Taponoto or Otocerum did not significantly improve the proportion of tympanic membranes that were completely visualized compared with saline solution when they were instilled 15 minutes before ear irrigation.

Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial.

Objectives To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1-7) with an 8-day follow-up (days 9-15). Outcome measures included change in itching from baseline (day 1) to study days 4-8 and 9-15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with placebo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4-8 and 9-15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.

Double-blind clinical trial to compare autologous fat grafts versus autologous fat grafts with PDGF: no effect of PDGF.

BACKGROUND: This work evaluates the effect of adding platelet-derived growth factor to autologous adipose tissue grafts in the treatment of human immunodeficiency virus facial lipoatrophy by means of objective measurements. METHODS: This is a randomized clinical trial conducted at the Hospital Clinic of Barcelona. Patients with facial human immunodeficiency virus atrophy were randomized into two groups, one treated with autologous fat injection (group A), and another treated with autologous fat injection with plasma rich in growth factors (group B). Before the treatment, structural changes were identified in facial soft tissue by means of computed tomography, and clinical changes were also assessed by means of photographic records. Posttreatment assessments were repeated after 2 and 12 months to compare the results. Posttreatment complications were recorded. RESULTS: Forty-nine patients (33 men and 16 women), with a mean age of 46 years, participated in the study. In both groups, there was a statistically significant average increase of volume in the facial area measured by computed tomography between the baseline and the 2- and 12-month posttreatment assessments. All cases showed an improvement of the clinical facial atrophy grade after treatment, which was statistically significant. This improvement was related to a statistically significant fat volume increase measured by means of computed tomography. There was no difference in the volume gain between both groups. No major complications were observed. CONCLUSIONS: Fat grafting is a safe, effective, and durable treatment for human immunodeficiency virus facial atrophy. The results of this study show that it is not necessary to add plasma rich in growth factors to the adipose tissue graft to get a better result. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.