Clinical development of wound management products

Wound management products require clinical efficacy data that often involves substantial proof of clinical benefit in comparison to other procedures and products. Companies also use such clinical competitive advantage to promote products through product claims and educational materials. As with most clinical evaluation the process of developing wound care products is risky, time-consuming, complex and expensive. The costs can be tens of thousands of dollars per patient for a clinical trial due to the expense of the patient setting, staffing and materials, and processing of the trial data. Long-term follow-up may be required to track the progress of wound healing to full closure of the wound (in chronic wound care situations), and to check that re-occurrence of the wound does not occur.

In general terms, the process of clinically evaluating new medical approaches proceeds through several phases; passing from “off-label usage” to “general approval” and then to “approval of many incremental developments.” Early in the modern era of wound management, physicians used technologies from other industries in improvisation mode because approved alternatives did not exist. An example of this was the off-label use of polyurethane film packaging materials for moist wound healing in the late 1970s. Often the next stage of approval is for new technologies to be clinically developed for specific critical diseases for which there is no alternative.

Once products have been clinically proven to be efficacious and safe, they are often approved initially for very specific applications. Another way that regulatory authorities may control the early use of products is to limit claims and indications to those that have been successfully confirmed in clinical trials. Companies are initially only allowed to promote and describe the use of products for these indications. These fields of use, and claims, are gradually broadened through extensive clinical trials and also reporting of off-label clinical use in peer-reviewed journals. General approval usually follows considerable volume use of the product and the passing of a number of years of safe use without adverse event reports. Concurrent with and following the period of expanded clinical evaluation, companies and investigators usually develop incremental improvements to the devices, such as improved methods of application, and in some cases procedure-enabling delivery systems.

Products in wound management include the following:

  • Film dressings
  • Hydrocolloid dressings
  • Foam dressings
  • Alginate dressings
  • Hydrogels
  • Non-adherent dressings
  • Anti-microbial dressings
  • Wound cleansers and debriding agents
  • Skin replacements and substitutes
  • Pharmacological products
  • Physical therapies (negative pressure, positive pressure, ultrasound, hyperbaric, electrical, etc.) 

See MedMarket Diligence report #S247, "Worldwide Wound Management Market, 2008-2017."

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