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Could An Emerging Biotechnology Solution Put An End To Costly Prolonged Care For Chronic Wounds?

Noting the challenges and costs of attempting to heal chronic wounds, this author suggests that a minimally invasive alternative to skin grafting could provide a viable option for patients. 

There is a chronic wound epidemic. Approximately 6.7 million Americans currently live with a chronic, non-healing wound.1 This number continues to rise, running parallel to our growing aging population and the increasing rates of diabetes and obesity.1

As a result, wound care puts a significant strain on the U.S. health-care system, creating an annual fiscal burden estimated at $50 billion.1 Many patients with chronic wounds often have other underlying conditions that can complicate their treatment and potentially lead to patients not showing up for appointments to complete their course of care. Even more alarming, among patients with diabetes who end up requiring lower-limb amputation, nearly 50 percent will die within five years.2

We must take action on improving the quality of care for these high-risk patients and reducing the time and costly nature of prolonged treatment. This is where innovations in biotechnology can have a true impact for providers and patients.

Until now, most chronic wounds required repeat visits for reapplication of wound dressings, compression therapy, debridement and/or the application of advanced cellular products among other treatments. But over time, if these wounds do not heal, these conventional approaches become quite costly to providers in outpatient settings, not to mention painful and very time-consuming for the patient. In my experience, I also find that patients’ adherence to home care visits and consistent appointment attendance is a barrier to healing. 

Prolonged wound care can also be challenging from a billing and reimbursement perspective. Although initial wound care can generate reimbursement for each episode of care, the payers (commercial and federal) can limit the number of reimbursements for products, like allografts, that often require several applications to generate results.

For patients who continue to have chronic, non-healing wounds, a common outcome when using products like allografts, the provider can generally only bill and receive reimbursement for the service rendered: debridement and application of graft for a certain amount of applications. This is less than ideal for both the care provider who can no longer bill for a necessary wound care procedure, such as application of additional grafts. 

Chronic wound care cases can quickly become loss leaders for all involved. With the rise of value-based care, in which reimbursement is increasingly tied to patient outcomes, the best care scenario for both patients and providers over the long-term is to get wounds healed as quickly as possible.

Recognizing Potential Challenges And Risks With Autografts And Allografts

Autografts do offer the benefit of allowing patients to serve as their own donors, which can help reduce rejection of the graft at the wound site. The surgeon can also expand autografts through meshing to increase the surface area. However, autografts are also invasive, create a larger or additional wound, have an additional risk of infection, and can cause emotional stress and physical pain for the patient.

Allografts, on the other hand, can be advantageous when sufficient autograft skin is not available or in cases where temporary coverage is more suitable. It can also alleviate the emotional stress and physical pain associated with harvesting skin (and thus creating an additional wound) from the patient’s body. The primary drawback and risk associated with allografts, however, is the higher rejection rate and increased number of applications needed. The cost of continued applications every week can also add up and be part of the patient expense. 

A Promising Alternative To Prolonged Wound Care

While there have been a number of innovations in wound care over the years, the emergence of autologous and homologous solutions, in which a patient’s own skin cells are used to grow skin grafts, may be particularly impactful. One obtains the cells through a one cm by one cm, minimally invasive shaving of the skin as opposed to creating a large, painful wound that can be common with standard skin grafting techniques. 

In my experience, physicians now employ this technique to help heal chronic wounds like venous leg ulcers and diabetic foot ulcers. As it only requires a small skin sample, this technique may be particularly beneficial for acute wounds, like burns and other trauma, when there may not be much healthy skin available to harvest. This regenerative approach not only eliminates the need to harvest large healthy patches of skin from elsewhere on the body but also anecdotally speeds healing and recovery times, and comes with a reduced risk of rejection as a patient is unlikely to reject his or her own cells. 

To date, I am aware that practitioners have successfully used these membrane sheets produced from the patient’s own cells to heal denuded areas in neonates, in the reconstruction of syndactyly cases, in burn wounds and other hard-to-heal wounds such as diabetic foot ulcers and venous leg ulcers.

In my own practice, I have used products like MyOwn Skin (BioLab Sciences) to treat patients with diabetic wounds who have not had success with standard wound care treatments. In my experience, using these advanced solutions reduces the need for repeated outpatient visits as most wounds will heal after a single application during an office visit. This could translate to a better patient experience, improved quality of life and a considerable cost-savings for providers and payers over the long-term. 

Final Notes

Could it be time to embrace the potential of tissue biomanufacturing and rethink our approach to lower extremity wound care? In my clinical experience, this appears to be a step in the right direction for our patients.

Dr. Roberts is in private practice in Tampa Bay, Fla. He is board-certified in foot surgery by the American Board of Foot and Ankle Surgery.

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By Eric Roberts, DPM
References

1. Zimmerman B. Current challenges and opportunities in wound care – 3 CNOs weigh in. Becker’s Clinical Leadership & Infection Control. Available at: https://www.beckershospitalreview.com/quality/current-challenges-and-opportunities-in-wound-care-3-cnos-weigh-in.html . Published May 11, 2018. Accessed October 26, 2020.

2. Gurney JK, Stanley J, Rumball-Smith J, York S, Sarfati D. Postoperative death after lower-limb amputation in a national prevalent cohort of patients with diabetes. Diabetes Care. 2018;41(6):1204-1211.

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