Originally Published: Dermagenics Inc.
Download PDF

Author:

J.A. van Loon

Summary:

This report summarizes the pre-market clinical evaluation and post-market clinical follow-up (PMCF) data for Tegaderm Matrix PHI, a sterile wound dressing. The document confirms that Tegaderm Matrix PHI dressings are clinically safe and perform as intended.

Here are the key points from the report:

• Product Description: Tegaderm Matrix PHI is a wound dressing impregnated with Polyhydrated Ionogens (PHI) ointment, a synthetic blend of trace elements and citric acid. It is intended for healing chronic wounds by normalizing the wound micro-environment and reducing inflammation. It can be used for both acute and chronic severe wounds such as burns, surgical wounds, leg ulcers, diabetic ulcers, and decubitus ulcers.
• Evolution of the Product: The product was initially marketed in Europe as Dermax in June 2002, with an oak bark extract (OBE) based ointment. A synthetic variant, Dermax PHI-5, received regulatory approval in Europe in October 2005. In 2009, it was marketed as Tegaderm Matrix PHI. The report states that clinical data from the OBE-based Dermax is suitable for evaluating Tegaderm because the only difference is the origin of the metal ions, not their type or concentration.
• Clinical Efficacy (Pre-market and PMCF):
  • Wound Healing: PMCF studies (2003-2006) reported that 78% of 60 wounds showed complete healing or improvement. Overall, the clinical performance of Tegaderm Matrix PHI was recognized as very effective.
  • Specific Wound Types:
    • Pressure Ulcers: A prospective study (2004) showed 100% full closure for Stage II and III pressure ulcers with an average healing time of less than six weeks. Stage IV ulcers showed a 12.5% healing rate.
    • Diabetic Foot Ulcers: A multicenter pilot study (2004) reported an overall full closure rate of 75%.
    • Leg Ulcers: Case studies (2005) demonstrated complete closure in two patients at 14 and 16 weeks.
  • Mechanism of Action: Studies showed that the formulation reduces reactive oxygen species (ROS) and regulates Matrix Metalloproteinases (MMPs), which are important for tissue degradation and regeneration in wound healing.
• Adverse Events/Side Effects:
  • Seven reports (4% of total wounds) described a stinging or burning pain sensation upon application, possibly due to citric acid content. This was more common in superficial leg ulcers than in pressure ulcers or diabetic foot ulcers (due to nerve damage/neuropathy).
  • Despite this, some studies, such as one by Dr. Dissemond, reported pain reduction after Dermax treatment.
  • No medical device-related adverse events have been reported for Dermax since its initial market introduction.
• Recommendations and Control Measures: For future PMCF studies, better analysis of ulcer type and underlying pathology is recommended. For painful arterial ulcers, combining the treatment with a more occlusive/moist secondary dressing (Hydrogel or Hydrocolloid) is suggested to reduce pain.
• Overall Conclusion: Based on the data, Tegaderm Matrix PHI dressings are concluded to be clinically safe and perform as intended, confirming the pre-clinical evaluation study outcomes.