OROPALLO CASE SERIES
PuraPly® AM demonstrated significant improvement
in wounds that had been stalled for two years1
objective
Prospective case series to assess the ability of PuraPly® AM to support granulation tissue formation and support wound closure over 12 weeks in chronic, nonhealing wounds.1
study design1
- A single-center, prospective case series (NCT03070925)
- Wounds were cleaned and prepared with sharp or mechanical debridement at initial visit
- PuraPly® AM was applied at week 0 and then every 1-3 weeks thereafter
- At each visit, wounds were assessed for signs of infection, wound area and depth, and achievement of closure
study subjects1
- A total of 41 wounds were included in the ITT analysis
- Wound types included were pressure ulcers (18), surgical wounds (9), VLUs (5), DFUs (4), and other (5)
- Median baseline wound area was 7.2 cm2 and mean depth was 0.58 mm
- Mean wound duration was 103.1 weeks
prior therapies Utilized before PuraPly® AM1
results1
- 73.2% (30/41) demonstrated an overall reduction in wound area over 12 weeks
- 36.6% (15/41) achieved complete wound closure with a mean time to closure
of 6.7 weeks - Increased granulation tissue was observed with healing of wounds
- Mean decrease in wound size of 7.5 cm2
Stalled,
Non-Healing Wounds
103 weeks
~ 2 years mean wound duration
Prospective case series1
Large Wounds
18.0 cm2
Baseline wound area1
Failed Multiple Therapies
of wounds had a
reduction in wound area1
of wounds closed1
6.7 weeks mean time tocomplete closure
WOUND CLOSURE (%) BY WOUND TYPE AT 4 AND 12 WEEKS1
1009080706050403020100
37.2
63.1
31.6
61.1
52.9
84.7
44.6
89.3
43.2
50.3
63.2
60.5
93.1
100
0
70.7
13.4
0
All
Pressure ulcer
Surgical wound
VLU
DFU
Ischemic wound
Trauma wound
GVHD wound
Other
Closure at Week 4 (%); n=41
Closure at Week 12 (%); n=35
Please refer to the PuraPly AM Instructions for Use and
PuraPly XT Instructions for Use for complete prescribing information.
References:
1. Oropallo AR. Plast Reconstr Surg Glob Open. 2019;7:e2047.