After a timely development, an optimization of the laNora breast pillow and the registration of the German and international patents, the Clinic for Plastic and Aesthetic Surgery of the St. Vinzenz Hospital in Cologne was able to register and begin a prospective clinical study on the pillows.
One of our goals for this study is to test the applicability of the breast pillow without medical concerns and without financial support. We are trying to determine if the pillow would deteriorate the outcome of the surgery when being used and if comfortable sleep can have a positive effect on healing.
The women who had breast surgery received a pillow after their stay in the clinic, which they could then test over a period of 5 weeks.
When the pillow is handed in, the patients then receive a standardized questionnaire which is filled in in compliance with the study doctor's GCP. It contains questions about the lying quality, possible pressure points, times of use as well as the question whether the pillow provided support in the sense of a relief when lying down.
In addition, there are a few more questions that are particularly relevant for plastic surgeons to prepare the clinical study.
The study is scheduled to run over a longer period of time and is expected to be completed in fall/winter 2021. After completion, the results will be published by the Clinic of Plastic and Aesthetic Surgery at St. Vinzenz Hospital in a peer review process.