Clinical evidence

GRAFIX Cryopreserved Placental Membrane shows high closure rates in the management of chronic wounds34


Study overview

  • Retrospective, single-center study
  • Patients: Treated with at least one application of GRAFIX Membrane within a 2-year period
  • 66 patients with a mean age of 71.1 years
  • Wound characteristics:
    • 75% had failed other advanced treatment modalities
    • Mean wound duration: 38 weeks
    • Mean wound size: 6.65 cm2
    • 67 wounds were analyzed*
  • Primary endpoint: Complete wound closure by week 12, confirmed by image analysis

Results

  • 76% of all wounds achieved complete closure by week 12
    • 85.2% of DFUs closed
    • 67.6% of VLUs closed
    • 83.3% of other wounds closed
  • Time to complete wound closure (mean): 5.8 weeks
  • Number of GRAFIX Membrane applications (mean): 3.8
  • 100% of closed wounds remained closed with a mean follow-up of 20.4 months (n=47)
76%

76% of all wounds achieved complete closure by week 12

100%

100% of closed wounds remained closed

Complete wound closure

Complete wound closure graph

Quartile 1: 0.42 cm2 - 1.80 cm2

Quartile 2: 1.81 cm2 - 3.37 cm2

Quartile 3: 3.38 cm2 - 6.56 cm2

Quartile 4: 6.57 cm2 - 59.18 cm2


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*34 VLUs, 27 DFUs and 6 other wounds (pressure ulcers, traumatic wounds, postsurgical wounds and non-venous vascular ulcers).