Clinical evidence

GRAFIX Cryopreserved placental membrane: Prospective study shows improved closure of chronic venous leg ulcers when added to standard of care29


Study overview

  • An investigator-initiated, retrospective, single-center study
  • The first and only comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting
  • All treated wounds inclusive of all durations, sizes, volumes, etiologies and locations that received at least one application of either graft, with one follow-up measurement, were included
  • Non-randomized, however statistically equal and homogenous patient cohorts
  • Statistical analysis was performed by a blinded third party

Patient demographics and comorbidities and wound characteristics

GRAFIX EpiFix P-Value*
Patients 40 39 0.649
Diabetic 25.0% 35.9% 0.292
Wounds 46 55 0.535
Wound (size) 7.7 cm2 7.0 cm2 0.769
Wound duration (mean) 150.9 days 212.8 days 0.107

Results

Complete wound closure: 63.0% for GRAFIX membrane versus 18.2% for EpiFix

90% of complete wound closure occurred by week 12

Complete wound closure graph

Closure rate with GRAFIX membrane was significantly higher

Additional considerations

  • Final percent area reduction (PAR) of 43.1% for GRAFIX membrane (n=17) versus -72.6% for EpiFix (n=45) (p=0.0382)*
  • Final percent volume reduction (PVR) of 36.9% for GRAFIX membrane (n=17) versus -135.7% for EpiFix (n=45) (p=0.0782)*

Baseline wounds surface area of closed wounds48

GRAFIX, EpiFix graph

Wounds closed with GRAFIX membrane were 4x larger

p<0.0201

*Based on chi-square test or Fisher’s exact test for categorical variables; t-test with Satterthwaite approximation for continuous variables.

†Based on number of patients with non-closed DFUs within initial 12 weeks.