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Background: Before performing the first face transplant in the United States, the authors addressed several ethical considerations: subject selection, adequacy of informed consent, and risk-to-benefit analysis. Methods: Destruction of the patient's midface, including its bony architecture, had impaired the ability of the authors' patient to speak, eat, smell, and socialize. These functional impairments and the inability of conventional reconstruction to reconstruct this deformity justified considering this patient for face transplantation. The patient's resilience in adapting to her injury, her conscientious self-care following her initial injury, and her ability to understand the risks and uncertainties of the proposed procedure were important factors in selecting her as a candidate for this innovation. To enhance our patient's understanding of this largely untried procedure, the informed consent process occurred over multiple encounters involving both information disclosure and assessment of comprehension of what the procedure involved, including its potential benefits and risks. The patient demonstrated not only understanding of the procedure, including its innovative nature and concomitant uncertainties, but also that its goals were consistent with her values. Results: Research risk-to-benefit analysis involved balancing societal and subject benefits against subject risks. The potential benefit to society and increased knowledge of the role of face transplantation in facial reconstruction were substantial. The subject's benefits had been maximized and harms minimized through subject selection, team expertise, and preparation. This produced a risk-to-benefit profile in which we considered that the benefits sufficiently outweighed the risks to proceed with transplantation in this patient. Conclusion: Ethical considerations were important determinants in the decision to proceed with facial transplantation in this woman.

The objective of this review article is to summarize the published details and media citations for all seven face transplants performed to date to point out deficiencies in those reports so as to provide the basis for examining where the field of face transplantation stands, and to act as a stimulus to enhance the quality of future reports and functional outcomes. Overall long-term function of facial alloflaps has been reported satisfactorily in all seven cases. Sensory recovery ranges between 3 and 6 months, and acceptable motor recovery ranges between 9 and 12 months. The risks and benefits of facial composite tissue allotransplantation, which involves mandatory lifelong immunosuppression analogous to kidney transplants, should be deliberated by each institution's multidisciplinary face transplant team. Face transplantation has been shown thus far to be a viable option in some patients suffering severe facial deficits which are not amenable to modern-day reconstructive technique.

Summary Background Multiple reconstructive procedures are common for the reconstruction of complex facial deformities of skin, soft tissues, bony structures, and functional subunits, such as the nose, lips, and eyelids. However, the results have been unsatisfactory. An innovative approach entailing a single surgical procedure of face allograft transplantation is a viable alternative and gives improved results. Methods On Dec 9, 2008, a 45-year-old woman with a history of severe midface trauma underwent near-total face transplantation in which 80% of her face was replaced with a tailored composite tissue allograft. We addressed issues of immunosuppressive therapy, psychological and ethical outcomes, and re-integration of the patient into society. Findings After the operation, the patient did well physically and psychologically, and tolerated immunosuppression without any major complication. Routine biopsy on day 47 after transplantation showed rejection of graft mucosa; however, a single bolus of corticosteroids reversed rejection. During the first 3 weeks after transplantation, the patient accepted her new face; 6 months after surgery, the functional outcome has been excellent. In contrast to her status before transplantation, the patient can now breathe through her nose, smell, taste, speak intelligibly, eat solid foods, and drink from a cup. Interpretation We show the feasibility of reconstruction of severely disfigured patients in a single surgical procedure using composite face allotransplantation. Therefore, this should be taken in consideration as an early option for severely disfigured patients. Funding None.

The aim is to discuss the various forms of bias in surgical research, including how it impacts validity and how to recognize and avoid it.The various factors affecting bias in surgical research's design, execution, and reporting were explored. The impact of these factors on internal and external validity in both observational and randomized controlled trials was examined, and recommendations were made for ameliorating the various biases.Identifying bias when interpreting a trial enables surgeons to assess surgical research's internal and external validity. Avoiding bias and/or using methods that minimize bias helps surgeons design and conduct trials with enhanced validity, which can be reliably translated into practice. To accomplish this, surgeons need to be cognizant of susceptibility bias, the applicability of surrogate endpoints, and the use of inappropriate comparators in trial design. They must also be aware of detection, ascertainment, performance and transfer bias in trial execution, and of citation bias in trial reporting.Familiarity with clinical trials' potential biases helps surgeons assess the believability and applicability of research results. Though these biases may sometimes be ameliorated by randomization, blinding, and intervention standardization, these remedies can present distinctive problems to surgical research. This poses a unique need and opportunity for innovation in surgical research design and evaluation. It necessitates that further research be done on methods to improve not only the internal and external validity of surgical trials but also their assessment.

The efficacy of TPN, with lipid as the major source of calories, was assessed with body composition measurements. A multiple isotope dilution technic was employed to measure body composition before, at two week intervals during, and at the completion of a course of TPN. All the patients received equal volumes of a 10 per cent Intralipid solution and a solution containing 7 per cent L-amino acids with 10 per cent fructose (Vamin). The mean daily change in exchangeable potassium (ΔKe/day), a measure of the mean daily change in the body cell mass, was correlated with the number of kcal/kg/day infused to determine the efficacy of the solution. The correlation was not statistically significant. However, it became statistically significant (p < 0.05) when the patients without malnutrition were excluded, as their body cell mass was not expected to increase regardless of the amount of calories and protein infused. The resultant regression line indicated that the body cell mass was maintained when 44.2 kcal/kg/day was infused. However, the slope of the curve indicated that the body cell mass did not increase significantly when calories in excess of this amount were infused. The Intralipid and Vamin combination successfully maintained a normal body cell mass but did not rebuild one that was depleted. In addition, the data emphasize the importance of knowledge of a patient's preexisting nutritional status in evaluating the response to TPN.