Effectiveness of the Asteame Nipple Guard™ in maintaining projection following nipple reconstruction: a prospective randomised controlled trial.

As the final step in breast reconstruction, nipple reconstruction is considered a minor surgical procedure. However, despite the multitude of techniques and postoperative dressings proposed, none have proven to resist the tendency of the reconstructed nipple to gradually flatten over time. A prospective randomized controlled trial was conducted assessing the value of using the Asteame Nipple Guard™ compared to standard gauze dressing in maintaining nipple projection postoperatively. A total of 30 nipple reconstructions in 22 patients were included in the study with randomisation of 15 nipples to each study arm. Nipple projection was measured at various time points postoperatively with calculation of the percent changes in nipple projection. The mean decrease in long-term nipple projection at 6 months in the experimental group was 46.6% vs. 71.8% in the control group (p<0.05). In conclusion, the Nipple Guard™ helps in maintaining nipple projection postoperatively. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

RCT Entities:   Population Interventions Outcomes