2019 International Consensus Includes Biofilm Treatment as New Standard of Care

The word breakthrough applies to some of the new treatment approaches described in the 2019 Journal of Wound Care Consensus document,¹ especially regarding biofilm. Growing international unity among wound care providers both underscores advancement in the specialty and indicates response to the challenges faced today.¹ The number of patients and nonhealing or hard-to-heal wounds are increasing, but the practice of wound care can seem ill-defined, yielding to personal preference practice and segmentation.^2,3 Adoption of a full-spectrum, synergistic medical solution as outlined in the Consensus document¹ provides real direction to strengthen foundational wound care knowledge, integrate evidence-based science, and allow each specialty contributing to wound management to individualize care beyond the basics to meet patient needs. Unsustainable costs to the health care system hover in the billions of dollars; current wound care practice needs to focus on what has been proven to work and demonstrate a heightened awareness of what is new.⁴  

Updates to TIME. The 2019 Consensus document¹ updates the bedside gold standard — wound bed preparation  — that wound care specialists have relied on for more than 19 years for predictable patient healing trajectories.^1,5  The successful paradigm TIME (T = tissue, I = infection/inflammation, M = moisture balance, E = edge of wound) for wound care has been updated to TIMERS; new sections covering regeneration/repair of tissue (R) and social factors (S) have been added, helping build a holistic approach that prompts initial definitive care at the first (baseline) visit.^6-8 The new document also clarifies confusion over healing trajectories by defining hard-to-heal refractory wounds as “any wound not healed by 40% to 50% after 4 weeks,” effectively standardizing markers that predict the ability of a wound to heal.¹ 

Biofilm. Significant discussions regarding the evidence and impact of biofilm indicate it was a top concern for the Consensus panelists. Described as a “key driver of nonhealing wounds,” biofilm stimulates a cycle of relentless chronicity. The panel collectively agreed the persistent inflammatory state must be reduced and that biofilm is a major confounder.⁹ One panel member said it best: “A wound that is impeded by biofilm but is not managed as such adds cost to the care and continued poor quality of life.”¹ That biofilm is present when a wound is not healing has been established through research; in fact, biofilm has been found to affect more than 90% of all nonhealing or chronic wounds.¹⁰ Empirical use of biofilm-directed care based on surrogate signs of biofilm, along with implementing a high standard of care that addresses risks and subclinical causes, can improve patient outcomes and (according to the panel) should be implemented at the initial patient visit. Affirming the pervasive nature of biofilm, the panel put forth a compelling message to merge findings identified through research and bring biofilm to the forefront in clinical practice.^11,12 

Original published work on wound bed preparation suggests inflammation and infection are central to wound chronicity.^8,13 Emerging research on inflammation and infection has revealed the complex nature of failure to heal is rooted in biofilm, exemplifying why updates to existing practice are needed and why change is inevitable. New and ongoing evidence has shown a synergy between delayed healing and the level of bioburden, fostering a fresh emphasis on the need for adequate biofilm treatment. The new biofilm practice paradigm encourages the concept of antimicrobial stewardship by emphasizing topical biofilm care as part of evidence-based treatment practices.¹⁴ Adding more information specific to the biofilm and inflammation body of evidence provides the perfect opportunity to eradicate biofilm without increasing the incidence of antibiotic use. The best practice approach to treating hard-to-heal wounds is to stem the overuse of antibiotics and address the root cause of inflammation and infection. 

Clinical wound presentation can be deceptive, but new evidence has given providers abundant data that lead them to agree microbial biofilm plays a clearly defined and substantial role in the majority of chronic wounds and an increasing number of acute wounds. The Consensus document¹ reinforces the belief that both time and timing are critical for patients with chronic and hard-to-heal wounds. Additionally, the Consensus document¹ provides a platform for change that can be understood and embraced, including real world steps in biofilm-directed care. Past biofilm care vacillated on a spectrum from contamination to critical colonization, generally focused on treating microbial wounds that exhibited clinical infection of 10⁵ colony forming units (CFU)/g of biopsy tissue. However, this scenario does not necessarily correlate with clinical presentations. Emerging research focuses on biofilm-directed care, which shifts the emphasis not only to destroying planktonic growth and defending against recolonization, but also to the structural nature of biofilm. Without bringing the bacteria-produced biofilm structure into play (dispersing or dissolving it), the biofilm extracellular polymeric substance (EPS) structure will persist. Studies regarding the tenacity of the EPS in protecting biofilm demonstrate the EPS can withstand steam sterilization on surgical instruments, resist harsh surface disinfectants, and rapidly regrow a biofilm in the face of disruption by ultrasonic and sharp debridement.^9,15,16 In fact, it is the physiochemical properties of the EPS rather than the bacteria that present the most formidable part of eradicating biofilm. Once formed, the EPS recruits metal ions such as iron, calcium, or magnesium from the wound environment, which help “weld” the polymers and structural elements of proteins and lipids to become a capsular-insoluble fortress. The mechanically stable EPS binds water and diffuses both antibiotics and antiseptics. Furthermore it absorbs nutritional elements for the bacteria, provides mass transport, displays optical properties that deflect UV light, and is friction-resistant.⁹ Flemming et al⁹  confirms that when biofilm is suspected, the cohesive and adhesive EPS forces must be resolved to overcome biofilm. Without chelating the bonds that hold the EPS together, biofilm is firmly entrenched.

Alignment of international wound treatment guidelines will need more than theoretical buy-in from wound care providers in order to advance. With the number of unresponsive wounds reaching a critical point, the Consensus panel stressed the need for a cohesive and collective treatment approach for hard-to-heal wounds. By blending previous versions of the TIME model of care with new and refined information, the panel recognized that clinicians often have no control over patient factors such as lifestyle habits, comorbid disease states, or regulatory bottlenecks that slow the uptake of new industry innovations. Current recommendations can be implemented with provider buy-in. The lack of knowledge is not what escalates wound care challenges; rather, it is the lack of implementing changes at the bedside that is the major roadblock to the reality of practicing evidence-based root cause medicine.⁴ As research evolves, so should treatment and clinical practice. Collectively, the recommended changes to patient care are based on peer-established endorsements that continue to produce strong clinical outcomes for those utilizing the new TIMERS framework. 

Dr. Stevenson is a clinical consultant, Next Science, Jacksonville, FL. Dr. Schultz is a professor, Department of Obstetrics & Gynecology; and Director, Institute for Wound Research, University of Florida, Gainesville, FL. The opinions and statements expressed herein are specific to the respective authors and not necessarily those of Next Science, Wound Management & Prevention, or HMP. This article was not subject to the Wound Management & Prevention peer-review process.