Although many technical descriptions of nipple reconstruction exist in the medical literature, insufficient evidence-based
data are present about the outcome. This study aimed to identify randomized controlled trials (RCTs) and controlled clinical
trials (CCTs) in the plastic surgical literature addressing nipple reconstruction, and to elucidate whether a hand search
was superior to an extensive database search in retrieving all pertinent studies. The hand search included analysis of all
“original articles” published in four of the leading plastic surgery journals from January 1990 to December 2005, with subsequent
identification of RCTs and CCTs. Additionally, a computerized search was conducted including the following databases: PubMed,
Web of Science, and Evidence-Based Medicine Reviews. From a total of 10,476 published original articles in four plastic surgery
journals over a 16-year period, only one RCT was identified that addressed nipple reconstruction. The database search, however,
retrieved two trials: the RCT identified by hand search and one CCT. The impact of nipple reconstruction is well described
in the literature. However, it is astonishing that the plastic surgical literature lacks evidence-based trials addressing
this issue. Clearly, more evidence-based trials are necessary to ensure that recommendations for a particular technique are
based on solid scientific data.
Keywords Controlled clinical trials - Evidence-based medicine - Nipple reconstruction - Randomized controlled trials