Publications library Consensus or guideline
IJTR · 2025
Serena, T.E. (Chair), Andersen, C., Bohn, G., Cosentino, G., Davis, M., Desvigne, M., Kaur, A., Low, M., Oropallo, A., Roselli, L., Sabatino, C., Simman, R., Slade, B., Tunyiswa, Z., & Wahab, N.
International Journal of Tissue Repair (IJTR)
This expert consensus document provides recommendations for designing and reporting randomized controlled trials of cellular, acellular, and matrix-like products (CAMPs) intended to support Medicare coverage. Drawing on a hierarchical Bayesian meta-analysis of 35 randomized controlled trials cited in Medicare's 2024 Local Coverage Determinations and an expert panel meeting held August 1, 2025, the panel recommends a documented run-in period with consistent standard of care, complete reporting of intent-to-treat and per-protocol data, a statistical analysis plan that justifies trial power, independent validation of primary endpoints, standardized wound-closure endpoints, patient-centered outcomes, racially diverse enrollment, nutritional screening, and evaluation in Medicare beneficiaries. The document also encourages master trial designs, research involving pressure injuries, and long-term follow-up studies.
Dr. Thomas Serena, SerenaGroup's founder, chaired the consensus panel.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
No abstract is published for this item. Use the full text link for the complete document.
