DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial.

INTRODUCTION: There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest. METHODS AND ANALYSIS: The study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor. ETHICS AND DISSEMINATION: The institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT03179020; Pre-results.

Field effect of two commercial preparations of botulinum toxin type A: a prospective, double-blind, randomized clinical trial.

BACKGROUND: The dose equivalence of commonly used commercial preparations of botulinum toxin type A, Dysport (abotulinumtoxinA [ABO] 500 U, Ipsen Biopharm Limited, Wrexham, United Kingdom) and Botox (onabotulinumtoxinA [ONA] 100 U, Allergan, Irvine, CA), remains unclear. OBJECTIVE: We sought to evaluate the field effect for ABO and ONA at dose equivalences of 2.5:1.0 U and 2.0:1.0 U, in both muscular and sweat gland activity. METHODS: In all, 59 female patients with forehead wrinkles were enrolled. Patients were randomized for dose equivalence between ABO and ONA, group A (2.0:1.0 U, ABO:ONA) or group B (2.5:1.0 U, ABO:ONA) administered in the frontalis muscles. Clinical assessment, Minor test, and electromyography evaluations were performed at baseline, 28 days, and 112 days. RESULTS: In group B, the field of anhidrotic effect of ABO showed a greater area and larger horizontal diameter than ONA at 28 and 112 days. At maximum frontalis muscle activity (day 112) patients receiving ABO demonstrated greater improvement based on the Wrinkle Severity Scale. No differences were found in frontalis muscle activity at rest between groups A and B based on results of Wrinkle Severity Scale, electromyography, and interindividual variability data at 28 and 112 days. LIMITATIONS: Currently, there are no objective measurements other than electromyography to evaluate the field effect of botulinum toxin type A in muscles. CONCLUSION: At a dose equivalence of 2.0:1.0 U (ABO:ONA), similar field effects were found for both muscle and sweat gland activity. At a higher dose equivalence of 2.5:1.0 U (ABO:ONA), injections of ABO showed greater area and larger horizontal diameter in field of anhidrotic effect at 28 and 112 days than ONA.

Side-by-side comparison of areas with and without cellulite depressions using magnetic resonance imaging.

BACKGROUND: Cellulite is characterized by alterations in the relief of the skin surface. Magnetic resonance imaging (MRI) is recognized as a reliable technique for measuring adipose volume according to body site and for the visualization of the subcutaneous structures. OBJECTIVE: To compare subcutaneous tissue in areas with and without cellulite on the buttocks of same subjects using a noninvasive technique. METHODS AND MATERIALS: Thirty female patients with cellulite on the buttocks underwent MRI. An area with cellulite and another without cellulite on the contralateral buttock were selected. Two soft gelatin capsules of different sizes were used as skin markers to differentiate the areas with and without cellulite. RESULTS: Fibrous septa were visualized in 96.7% of the area with cellulite depressions; most of them were ramified (73.3%) and presented a high-intensity signal on T2 images (70%). All fibrous septa found in the examined areas were perpendicular to the skin surface. The average fibrous septa thickness was 2.18 +/- 0.89 in the area with cellulite and 0.27 +/- 0.64 in the area without cellulite. CONCLUSION: Results of the MRI analysis showed that cellulite depressions on the buttocks were significantly associated with the presence of underlying fibrous septa.

Blind multicenter study of the efficacy and safety of injections of a commercial preparation of botulinum toxin type A reconstituted up to 15 days before injection.

BACKGROUND: It is recommended that attention be given to the shelf life of botulinum toxin type A (BT-A) after its reconstitution. OBJECTIVE: To assess the efficacy and safety of 500 U of BT-A after reconstitution up to 15 days after injection. MATERIAL AND METHODS: BT-A vials were diluted 15 days, 8 days, and 8 hours before injection. One hundred five volunteers were randomized to one of three treatment groups, according to dilution dates. They were evaluated at baseline and 28, 56, 84, and 112 days after treatment. At each visit, the investigator and the volunteer evaluated the motility of the treated area using a 4-point qualitative scale. Five independent specialists, who scored the motility of the treated area on the same scale, blind analyzed photographs taken at each visit. The reconstituted vials of BT-A were stored and analyzed before and after the study. RESULTS: No significant difference was shown between the groups. No evidence of contamination was found in the BT-A vials. CONCLUSION: The results confirm the possibility of injecting 500 U of BT-A up to 15 days after its reconstitution safely and without loss of efficacy.

A randomized pilot study comparing the action halos of two commercial preparations of botulinum toxin type A.

BACKGROUND: The determination of the action halos of botulinum toxin type A aids in targeting specific muscles and/or sweat glands, thereby preventing the occurrence of side effects. OBJECTIVES: The objective of this study was to compare the action halos of two commercial preparations of botulinum toxin type A, Dysport (Ipsen, Slough, UK) and BOTOX (Allergan, Irvine, CA). MATERIAL AND METHODS: Eighteen volunteers received applications of both products into randomized sides of the frontalis muscle. Equivalent doses of 5 U of Dysport and 2 U of BOTOX were injected using the same technique, in the same volume (0.02 mL), and at a controlled depth. Twenty-eight days later, clinical and photographic assessments were performed. RESULTS: All the areas around the injected points were regular, round, or slightly oval and showed similar effects in the muscles and sweat glands. No statistically significant differences were observed between the mean sizes of the diameters of the halos produced by the two products. CONCLUSION: Injections of Dysport and BOTOX at an equivalence ratio of 2.5:1 U, respectively, applied at the same volume and depth, using the same technique resulted in similar action halos with regard to muscular and sweat gland activity. Both products seem to be safe and very predictable.