Clinical research in aesthetic surgery.

Clinical research in aesthetic surgery cannot use traditional objective measures of surgical success. Present research designs and methods used in aesthetic surgery limit the ability to conduct meaningful clinical research. Outcomes research may be ideally suited for assessing patients in aesthetic surgery. A critical aspect of an outcomes-based approach is to select appropriate instruments for investigations. Widely accepted, standardized methods for assessing outcomes would allow for comparison of surgical techniques and provide a common basis for clinical investigations.

Mortality in patients with necrotizing fasciitis.

BACKGROUND: The prognostic factors that determine outcome in patients with necrotizing fasciitis remain poorly understood. The aim of this study was to analyze the variables that affect the mortality and morbidity of patients with necrotizing fasciitis and to create a simple method for estimating the probability of mortality. METHODS: The authors undertook a retrospective review of all patients with necrotizing fasciitis treated in three tertiary care hospitals in Ontario, Canada, between January of 1994 and June of 2001. Demographic, comorbid illness, and disease-specific data were collated and analyzed for associations with outcome. Using logistic regression analysis, probability estimates for the prediction of mortality were developed, based on three contributing independent factors. RESULTS: Ninety-nine patients satisfied the inclusion criteria. Overall mortality was 20 percent. Sixteen patients suffered from amputation or organ loss. The most common comorbidities were diabetes (30 percent), immunocompromised status (17 percent), and chickenpox (11 percent). Advanced age (odds ratio, 1.04; 95 percent confidence interval, 1.01 to 1.08; p = 0.012), streptococcal toxic shock syndrome (odds ratio, 10.54; 95 percent confidence interval, 2.80 to 39.44; p < 0.001), and immunocompromised status (odds ratio, 3.97; 95 percent confidence interval, 1.04 to 15.19; p = 0.044) were independent predictors of mortality and were used to design a formula for the probability of mortality. CONCLUSIONS: Age, streptococcal toxic shock syndrome, and immune status are significant determinants of mortality and can predict the probability of death from necrotizing fasciitis soon after admission. This objective information can guide clinicians in communication with patients and in making clinical decisions.

Inhibition of microsurgical thrombosis by the platelet glycoprotein IIb/IIIa antagonist SR121566A.

Despite major improvements in tools and significant refinements of techniques, microsurgical anastomosis still carries a significant risk of failure due to microvascular thrombosis. The key to improving the success of microvascular surgery may lie in the pharmacologic control of thrombus formation. Central to pathologic arterial thrombosis are platelets. Glycoprotein IIb/IIIa is a highly abundant platelet surface receptor that plays a major role in platelet aggregation by binding platelets to each other through the coagulation factor fibrinogen. To explore the ability of antithrombotic agents to prevent microvascular thrombosis, a rabbit ear artery model was used in which a standardized arterial injury results in predictable thrombus formation. This model was used to examine whether SR121566A, a specific and potent glycoprotein IIb/IIIa inhibitor, can successfully prevent microsurgical thrombosis. Using a coded, double-blind experimental design, 20 rabbits (40 arteries) were assigned to four treatment groups: (1) saline injection (n = 10), (2) acetylsalicylic acid 10 mg/kg (n = 10), (3) heparin 0.5 mg/kg bolus with subsequent intermittent boluses of 0.25 mg/kg every 30 minutes (n = 10), and (4) SR121566A 2 mg/kg bolus (n = 10). After vessel damage and clamp release, arteries were assessed for patency at 5, 30, and 120 minutes by the Acland refill test. Coagulation assays, in vivo bleeding times, and ex vivo platelet aggregation studies were also conducted. Scanning electron microscopy was used to examine mural thrombus composition.A significant, fourfold increase in vessel patency following administration of SR121566A over saline control (80 percent versus 20 percent patency, respectively, at 35 minutes after reperfusion, p < 0.01) was noted. This was correlated with marked inhibition of ex vivo platelet aggregation. This antiplatelet treatment did not prolong coagulation assays (mean international normalized ratio: saline, 0.66 +/- 0.04; SR121566A, 0.64 +/- 0.03; mean thromboplastin time: saline, 19.63 +/- 0.67; SR121566A, 17.87 +/- 3.27) and bleeding times (mean bleeding time: saline, 42 +/- 4; SR121566A, 48 +/- 6). Scanning electron microscopy demonstrated extensive platelet and fibrin deposition in control vessel thrombi. In contrast, thrombi from SR121566A-treated vessels demonstrated predominance of fibrin with few platelets when examined under scanning electron microscopy.Administration of SR121566A was associated with a significant increase in vessel patency, without deleterious effects on coagulation assays or bleeding times. The increase in vessel patency was correlated with inhibition of platelet aggregation and decreased platelet deposition, as demonstrated by scanning electron microscopy. Glycoprotein IIb/IIIa antagonists represent a new class of anti-platelet agents that may be suited for inhibiting microsurgical thrombosis. This study supports further investigation into the use of these agents in microsurgery.

Measuring outcomes in aesthetic surgery: a comprehensive review of the literature.

Outcomes research examines the end results of medical interventions, taking into account patients' experiences, preferences, and values. The purpose of assessing outcomes is to provide evidence on which to base clinical decisions. The assessment of outcomes in aesthetic surgery is especially pertinent because patient satisfaction is the predominant factor in determining success. In cosmetic surgery, various scales have been used to assess outcomes. Unfortunately, none of these methods has achieved widespread use. The adoption of broadly accepted, relevant scales to measure outcomes would be advantageous, because this would allow the comparison of techniques, quantification of positive effects, and identification of patients unlikely to benefit from surgery. The purpose of this study was to critically review the present literature to identify the appropriate instruments to assess outcomes in aesthetic surgery. After a comprehensive review of aesthetic surgery outcome instruments, the authors identified body-image and quality-of-life measures to be of the greatest value in determining aesthetic surgery outcomes. These conclusions were based on a critical evaluation of the feasibility, validity, reliability, and sensitivity to change of these measures. The Multidimensional Body-States Relations Questionnaire (MBSRQ), a psychological assessment of body image, was selected as a potential candidate for further study. Two additional body-image assessment instruments, the Facial Appearance Sorting Test (FAST) and the Breast Chest Ratings Scale (BCRS), may be useful in the assessment of rhinoplasty and breast surgery, respectively. The Derriford Scale (DAS59), an instrument that assesses appearance-related quality of life, was also selected. In addition, the authors recommend the use of a generic, utility-based quality-of-life instrument, such as the Health Utilities Index (HUI) or the EuroQol (EQ-5D).