statistical underpinnings of an equivalency or noninfe- riority trial require that an initial difference in outcomes between groups be designated as a clinically relevant difference. Adhering to a strict interpretation of the re- sults of the equivalency trial, one can only make conclu- sions with respect to the difference in outcomes initially designated. For our study, we chose 6% as that desig- nated difference, to avoid a potentially meaningless dif- ference in infection rate between groups, which might be statistically different but not clinically relevant. This was balanced with the sample size requirements for a smaller equivalence threshold. In Dr Lee’s example for comparing 9% infection rate for paint-only versus 4% in paint-plus-scrub, the sample size requirements would be approximately 650 patients per group (1,300 patients total). We have contributed to the literature a controlled clinical trial that was designed to test the idea that pre- operative scrubbing of skin with povidone-iodine soap adds no incremental protection against wound infec- tion. We do not agree with Dr Lee that our results have the same interpretation as a hypothetical trial, where the actual infection frequency was 9% in the paint-only arm and 4% in the paint-plus-scrub arm. Although Dr Lee’s worst-case outcomes would be within the tolerance of our 6% equivalence threshold based on our current re- sults and the results of previous trials, that specific out- come would be unlikely given the data that has been reported as of this writing. Admittedly, Dr Lee is correct that the interpretation of our results has not added to the possible knowledge-space: povidone-iodine scrubbing might add benefit, might have no effect at all, or might actually increase infection likelihood. Statistical rea- soning does not deal in perfect knowledge states. It can lead to conclusions that speak to the likelihood of outcomes. We would argue that our data have shown that the advantage of povidone-iodine scrubbing over paint-only is minimal at best because it is the most likely interpretation. Despite the results of even the most rigorously de- signed single clinical trial, the thoughtful clinician will always weigh the pros and cons of altering his or her clinical practice. Results of our single clinical trial must be interpreted in the context of the four earlier clinical trials available for review, all of which are cited in our publication. Each of these was a negative trial, and each trial compared the “gold standard” scrub-plus-paint to something different and often less than scrub-plus- paint. In view of this body of literature and our clearly negative clinical trial, an objective observer who is not lost in the vagaries of statistical minutiae, can conclude that a reasonable argument can be made for abandoning scrub-and-paint. Delayed Massive Hemorrhage after Pancreaticoduodenectomy: A New Therapeutic Approach Giuseppe Navarra, MD Marcello Bartolotta, MD Adalberto Barbera, MD Messina, Italy We read with great interest the series of delayed massive hemorrhages after pancreaticoduodenectomy reported by Tien and colleagues 1 in your journal. They have con- firmed that delayed massive hemorrhage after pancreati- coduodenectomy, often associated with septic complica- tions secondary to leakage or intraabdominal abscess, is still a frequent event carrying a high mortality rate. After the failure of conservative management, final manage- ment can be either radiologic or surgical, as stated by Tien and colleagues. 1 Although radiologic management is partly dependent on resuscitation facilities at the de- partment of radiology and the prompt availability of experienced interventional radiologists, surgical man- agement is much more invasive and brings with it high morbidity and mortality, even if it succeeds in stopping the bleeding. But there is a pharmacologic agent that can be used as rescue treatment in case of massive bleeding: recombinant activated factor VII (rFVIIa), which we used to treat a case of delayed massive hemorrhage after pancreaticoduodenectomy. Recombinant FVIIa is a major alternative for man- agement of hemophiliac patients with inhibitors. 2 More recently, it has been used off-label to control bleeding in patients with trauma or other massive life-threatening hemorrhage, and to reduce blood loss in surgical pa- tients with normal coagulation. 3-5 Recombinant FVIIa binds to activated platelets independently of tissue fac- tor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular injury makes it an attractive potential treatment for massive, uncontrolled bleeding. 854 Navva J Am Coll Surg