Clinical study

GRAFIX PL Membrane: Retrospective study suggests clinical equivalency with GRAFIX◊ Cryopreserved Placental Membrane10

Study overview

Retrospective, open-label, multi-center study on GRAFIX PL Membrane in the management of chronic wounds*

Wounds included DFUs (n=41), VLUs (n=19), surgical wounds (n=10) and other wounds (n=28)†

Patient demographics and baseline wound characteristics
Patients 78
Wounds 98
Patients with ≥ 2 comorbidities 65%
Wound size (mean) 13.3 cm2
Wound duration prior to treatment (mean) 8.7 months

Results

Complete wound closure: 59.2%

GRAFIX PL Membrane closure rates similar to those previously reported for GRAFIX Membrane:

  • Time to closure (median): 63 days
  • Number of graft applications (median): 6 grafts

Proportion of patients who achieved closure10

Proportion of patients who achieved closure graph

Median days to closure10,16

Median days to closure graph

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*Defined as wounds with no progression toward closure with 4 weeks of SOC or wounds in patients with significant comorbidities that put them at high risk for nonclosure.

†Other wounds include pressure ulcers, arterial wounds, chronic wounds, open hematomas, gangrenous wounds, radiation necrosis wounds, lymphedema wounds, ischemic wounds, & necrotizing fasciitis.