
Thinking Beyond Closure with Dr. Thomas Serena
What happens when reimbursement pressures, regulatory requirements, clinical research, and innovation collide? In this episode of the Open Wound Research Podcast, Dr. Thomas Serena takes us through the rapidly changing landscape of wound care research. Drawing on decades of experience as a clinician, researcher, and advisor to industry and regulators, he shares his perspective on everything from Medicare reimbursement and evidence requirements to master trial designs, Bayesian statistics, precision control groups, and the growing importance of patient-centered outcomes. We also explore how clinical research is expanding beyond traditional wound care into diagnostics, burns, dermatology, antimicrobial research, and new technologies—and why the next generation of wound-care innovation may depend on better data, better trial designs, and a willingness to rethink traditional endpoints. From the challenges facing providers and manufacturers today to the opportunities emerging for the future, this is a wide-ranging conversation about where wound care research is heading next. Links from the episode: SerenaGroup - https://serenagroups.com/woundclinicaltrials Apligraf - https://www.apligraf.com/ TRSS Tissue Repair Summit - https://podiatrymeetings.com/event/trss-tissue-repair-summit/ SAWC - https://www.hmpglobalevents.com/sawcfall MolecuLite - https://moleculight.com/ US Wound Registry - https://uswoundregistry.com/about/ WCCC - https://www.woundcarecc.org/ Dr. Thomas Serena on LinkedIn - https://www.linkedin.com/in/thomas-serena-md-facs-46683bb/ Timestamps: 00:00 Intro and origin story 12:14 Skin Substitutes & Hyperbarics 17:40 Evidence-Driven Reimbursement 25:53 FDA & CMS Pathways 32:13 Global Clinical Research 43:09 Dermatology in Wound Care 46:21 Adaptive & Platform Trials 47:39 FDA Registry Trials 54:49 Emerging Wound Care Technologies 58:02 Outcomes-Based Reimbursement 1:00:14 Closing question Follow us: LinkedIn: https://www.linkedin.com/company/90449662/ Thanks for listening!










