Improving Post-Operative Monitoring of Autologous Breast Reconstruction: A Novel, Oxygen-Sensing Liquid Bandage First-in-Human Trial
Alexandra Bucknor, MBBS, MSc1, Parisa Kamali, MD1,2, Haley Marks, PhD3, Emmanuel Roussakis, PhD3, Nicholas H. Nowell, BS3, Conor L. Evans, PhD3, Samuel J. Lin, MD, MBA1.
1Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA, 2Radboud University Medical Center, Nijmegen, Netherlands, 3Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, MA, USA.
Autologous free flaps may be used to reconstruct defects arising in a variety of contexts, including trauma and cancer. With improving microsurgical techniques flap failure rates are decreasing; however, this devastating complication may still occur in up to 5% of cases. In this study, we present results of a first in-human trial of a new, non-invasive, optical oxygen-sensing liquid bandage (OSLB) formulation in post-operative monitoring of tissue perfusion.
Four women undergoing mastectomy and deep inferior epigastric artery perforator (DIEP) flap reconstruction were prospectively enrolled from February-June 2017. In addition to standard post-operative monitoring with near-infrared spectroscopy tissue oximetry (ViOptix), the OSLB was painted on the flap skin paddle. The formulation consists of New-Skin™ liquid bandage, incorporating an oxygen-sensing metallo-porphyrin exhibiting bright red phosphorescence and the green-fluorescing reference dye: fluorescein. Using a custom-modified camera with red and green filters, we captured phosphorescence and fluorescence, respectively, at regular time periods for 48 hours post-operatively. The relative phosphorescence intensity was calculated.
Three Caucasian and one African American woman took part. Two cases were bilateral, producing a total of six breasts. When comparing the OSLB red/green ratio with the ViOptix, an inverse correlation was observed, as expected. Notably, this persisted for an African American patient with Fitzpatrick Type V skin. No complications or flap losses occurred.
The success of attempted flap salvage is highly reliant on early identification of flap compromise and prompt re-exploration. Results show that OSLB phosphorescence intensity correlates well with the stO2 values provided by our current gold standard of care, the ViOptix. The OSLB proved easy to apply and remove, was well-tolerated, and enabled visualization of flap skin due to its intrinsic transparency. Moreover, we demonstrated successful use of the OSLB in a patient with Fitzpatrick type V skin. This oxygen-sensing liquid bandage offers reproducible, accurate detection of tissue oxygenation. Further research is needed to validate this technology on a larger scale.
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