Studies

STRAVIX Cryopreserved Umbilical Tissue in the management of challenging wounds14,15


Soft tissue defects in patients with gas gangrene14

Study overview

  • Retrospective, single-center study of STRAVIX Tissue in the surgical management of large soft tissue defects in patients with gas gangrene (n=10)
  • Medical histories include coronary artery disease, congestive heart failure, anemia, hypertension and peripheral arterial disease
  • Patients: 10
    • Age (mean): 59.8 years
    • BMI (mean): 28.6 kg/m2
    • NPWT used: 9/10 patients
    • Wound size (mean): 45.9 cm2
    • Lower extremity gas gangrene
    • History of diabetes

Procedure

  • Surgical intervention resulting in large, open defect with exposed bone / tendon / soft tissue
  • Inadequate surrounding soft tissue or skin for surgical wound closure
  • Not candidates for autologous skin grafting/flaps

Results

All patients achieved complete wound closure following a single STRAVIX Tissue application:

  • 13.4 weeks for wound closure (mean)
  • 9 days of hospital stay (mean) versus 31.1 days of hospital stay (mean) in a database review of 11,666 patients with gas gangrene in the foot2
  • 68.4% percent area reduction at 4 weeks (mean)
  • Restoration of natural pigmentation

INTRA-OP

2 WEEKS POST-OP

4 WEEKS POST-OP

18 WEEKS POST-OP

20 WEEKS POST-OP


Complex wounds15

Study overview

  • Prospective, single-center pilot study of a single application of STRAVIX Tissue in the management of complex wounds*
  • 10 patients with 12 wounds** (VLUs, DFUs, pressure ulcers, traumatic wounds, and a surgical wound):
    • Baseline wound area (mean) – 16.5 cm2
    • Wound duration (mean) – 10 months***
  • Medical histories include: diabetes (60%), HTN (60%), hyperlipidemia (40%), CAD (30%), venous insufficiency (20%), kidney disease (10%)

Results

Primary endpoint – patients with 100% granulation in 4 weeks or earlier: 80.0%

Time to 100% granulation (mean): 17.5 days

Patients with complete closure in 4 weeks or earlier: 30.0%


*Wound with exposed bone, tendon, muscle, hardware or other underlying structure

**Intent to treat population was 10 patients with 12 wounds. Two patients did not complete all 4 weeks of the study and were excluded from the outcome analyses. The remaining 8 patients with 10 wounds constituted the per protocol population

***Wound duration was unknown for one patient