How can the world of wound care better embrace innovation, improve patient care, and overcome challenges? Consensus recommendations from a recently published article outline experts’ thoughts on these issues.

In May 2024, a group of 32 participants with backgrounds in clinical practice, surgery, industry, academia, and research took part in multiple panel discussions hosted by the Wound Care Collaborative Community (WCCC) at a meeting in Orlando, Florida. Their goal was to develop consensus recommendations addressing current deficiencies in wound care and promoting improved innovation and patient access. Over the course of 5 panel discussions, followed by email correspondence and a formal survey, 12 consensus statements were created.  

Each of the 5 panel discussions addressed a specific topic: addressing barriers to wound care, alternative primary and co-primary endpoints, generating and reporting evidence, real-world evidence in FDA and payer decision-making, and defining standard of care in wound care.

As a result of these discussions, the WCCC expert panel has published the following consensus statements¹:
1.    Investor hesitancy resulting from poorly executed clinical trials, poor clinical trial design, and/or insufficient endpoints hinders innovation in wound care.
2.    Improved and efficient methods of RWD collection (eg, an industry-wide registry) could help define accurate patient populations for clinical trial selection and improve the likelihood of success.
3.    Complete wound closure remains the gold standard in primary endpoints for clinical trial design.
4.    If complete wound closure is unattainable, clinical trial designs can be carefully designed to incorporate alternative endpoints, targeting both a meaningful degree of wound area reduction and a clinically meaningful outcome for patients.
5.    Innovative tools, devices, products, or diagnostics must accurately and reproducibly measure primary endpoints and provide reliable consistency across study results.
6.    The wound care community has a significant need for updated clinical trial reporting guidelines.
7.    Established clinical trial reporting guidelines should be communicated with national and international journals, associations, and conferences for successful adoption. When the entire community agrees to use the same standard, the guidelines will carry the most weight in calibrating published studies.
8.    Accurate and updated ICD-10 codes for wound care are urgently needed.
9.    Standardized, universal data entry metrics are needed to help calibrate results between RWE and RCTs.
10.    As the FDA does not regulate SOC or the practice of medicine, professional practice organizations must define their own SOC.
11.    The SOC should be specific and granular, with reasonable parameters to eliminate trial inconsistencies while allowing flexibility for patient-specific needs.
12.    The entire Wound Healing Collaborative Community and its stakeholders must be held accountable for consistently implementing the established SOC.

A recent paper in Wounds, “Collaboration Encourages Innovation: Setting New Standards in Wound Care With the Wound Care Collaborative Community Expert Panel Consensus Recommendations,” discusses the background and experience of panel members, as well as the process of coming to each consensus statement. Moreover, each statement is described to illustrate its importance and aim in improving the field of wound care. The work of the WCCC and its stakeholders, including the conversations that occurred during this summit, represent a significant step forward in identifying the need to develop standards and helping to drive funding and innovation in hopes of providing meaningful change for patients.

Reference
1.    Driver VR, Walthall H, Oropallo A, et al. Collaboration encourages innovation: setting new standards in wound care with the Wound Care Collaborative Community expert panel consensus recommendations. Wounds. 2024;36(12):410-418. doi:10.25270/wnds/24186