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Compliance In Focus
Posted by John Lehmann on Tue, May 21, 2019

New Medical Device Helps Wounds Heal Faster

A new wound care device can help patients heal faster by detecting potentially harmful bacteria in wounds, allowing for more targeted treatment.

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The MolecuLight i:X is a noninvasive, handheld fluorescent imaging device that emits a violet light, illuminating bacteria not visible to the naked eye.

This can improve wound care at every stage, from assessment and cleaning to debridement and treatment.

Here’s a closer look at how it works and why it represents a significant advancement in wound care.

How The Wound Care Imaging Device Works

Bacteria can infect open wounds, hindering the healing process. Wounds with dead tissue are more susceptible to bacteria. That’s why regular debridement—or removal of necrotic and devitalized tissue—is an important part of wound care.

Standard wound care requires unhealthy tissue to be debrided to detect underlying bacterial contamination. This can prevent harmful infections like staph infections, methicillin-resistant staphylococcus (MRSA) and E. coli.

This new wound care device detects bacteria on and beneath the surface of wounds, helping physicians make more informed decisions about how to treat the wound, according to an article in Today’s Wound Clinic.

The device also contains wound area measurement software that automatically detects the wound border and generates instant, precise wound measurements. Having accurate measurements on the area, length and width of the wound helps physicians better assess the wound and measure progress.

According to the MolecuLight i:X website, the wound care device also helps with:

  • Wound sampling
  • Wound documentation
  • Antibiotic selection
  • Patient engagement, or helping patients better understand their treatment

Results of Using The New Wound Care Device

In an analysis of five men and five women with different types of wounds (including traumatic wounds, leg ulcers and diabetic foot ulcers), the wound care device assisted in treatment in various ways, including:

  • Detecting early cellulitis in one patient, allowing for early treatment and preventing potential hospitalization
  • Substantially decreasing bacteria and wound depth in a patient with a traumatic wound
  • Allowing a woman with a traumatic wound to receive treatments at home, avoiding a hospital stay

In addition to preventing infections and reducing the time it takes for wounds to heal, new wound care device can also make wound care more cost-effective. Clinical studies in Canada (cited in a Podiatry Today article) have demonstrated up to an 89 percent reduction in the cost of treating wounds, compared to standard care.

The Future of Wound Care

If wound care devices like this one are any indication, we can expect the future of wound care to be more targeted, personalized and informed by advanced imaging and data.

However, clinical trials on wound care devices are inherently complex. They require continual assessment of protocol requirements, including eligibility criteria, and prompt follow-up is critical. It’s also important for researchers to use a consistent method for evaluating the progress of wound healing.

IMARC has extensive experience monitoring complex wound care device trials, with a staff of monitors and auditors who are considered experts in the clinical research regulations that govern medical device research, including 21 CFR 812, 21 CFR 50, 21 CFR 56, 21 CFR 54, and 21 CFR 11.

In addition to having solid experience in the cardiovascular, neurological, and orthopedic areas, among others, our team has monitored and audited various types of wound studies, including:

  • Porcine-based wound matrices being tested in full thickness pressure ulcers, full thickness diabetic ulcers, and full thickness venous ulcers
  • Wound closure products aimed at improving healing time for surgical wounds
  • Porcine-based wound product to aid in the healing of persistent anal fistulas

If you are exploring a new wound care device or any other type of medical device, we have the experience and therapeutic expertise to assist you at every stage in your trial. We can provide consulting, training and independent third-party oversight, ensuring patient protection and data integrity.

Contact us today to learn more about how we can help.

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Topics: Wound Care

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