complete
RETAINS ALL native LAYERS
proven
NuShield® is a complete, multi-layered dehydrated placental allograft that provides a protective barrier
RETAINS ALL native LAYERS
NuShield® is a complete, multi-layered dehydrated placental allograft that provides a protective barrier
NOVEL PRESERVATION METHOD
NuShield® provides a protective barrier and the LayerLoc™ preservation method retains:
*Vancomycin and gentamicin are used during tissue processing. Caution should be exercised on patients with known sensitivity or allergies to these or any of the processing agents listed in the Instructions for Use.
NuShield retains all native amnion and chorion layers, including the spongy layer, and may be used as a protective barrier
randomized controlled trial
for protective barrier use
Cazzell SM, et al
Prospective, multicenter, randomized controlled trial in diabetic foot ulcers (DFUs); N=218
frequency of wound closure*
When NuShield was used as a protective barrier as part of the course of wound management
When NuShield was used as a protective barrier as part of the course of wound management
Greater probability of wound closure‡
Median time to wound closure§
SOC failed to attain this endpoint at 12 weeks
* Estimated frequency of wound closure based on Cox adjusted survival data.
† Debridement, infection management, wound cleaning, dressings, and offloading.
‡ Probability of wound closure based on Cox regression hazard ratio.
§ Time to wound closure evaluated using the Kaplan-Meier method.
DFU=diabetic foot ulcer; SOC=standard of care
Change from baseline wound area
When NuShield was used as a protective barrier as part of the course of wound management
PROPORTION OF SUBJECTS
ACHIEVING ≥40% WOUND CLOSURE
When NuShield was used as a protective barrier as part of the course of wound management
Stratum 1: DFUs <4cm2
Stratum 2: DFUs ≥4cm2
real-world
for protective barrier use
Caporusso J, et al
In real-world patients (retrospective case series), NuShield® was used as a protective barrier in a wide variety of wounds (N=50), including:
Median time to wound closure
When NuShield was used as a protective barrier as part of the course of wound management
Estimated median time to wound closure for all wounds from a Cox regression model with terms for age, sex, wound type, wound duration, baseline wound area, and duration in clinic. Test of equality over strata: P=0.071 (Wilcoxon).
PERCENTAGE OF WOUNDS CLOSED BY WEEK
When NuShield was used as a protective barrier as part of the course of wound management
achieved complete
closure at 16 weeks
achieved complete
closure at 24 weeks
Of those wounds that did not achieve wound closure, 9 (18%) had >90% wound closure, and 8 (16%) had wound closures ranging from 60% to 90% by the last observation.
* All wounds include DFUs, VLUs, and other wounds.
† Other includes 3 pressure injuries, 4 nonhealing surgical, 1 ischemic, 1 mixed etiology, 1 nonhealing amputation, and 1 not identified.
Estimated frequency of wound closure for all wounds from a Cox regression model with terms for age, sex, wound type, wound duration, baseline wound area, and duration in clinic. Test of equality over strata: P=0.071 (Wilcoxon).
VERSATILE PROTECTIVE BARRIER
| Product Number | Product Description | Total Size (cm2) | Billable Units | HCPCS Code | UPC/GTIN |
|---|---|---|---|---|---|
| NO-1160c | 1.6cm disc | 1.6 disc | 2 | Q4160 | 00857877005160 |
| NO-1250 | 2.5x2.5cm | 6.25 | 7 | Q4160 | 00618474000565 |
| NO-1320 | 3.2x3.2cm | 10.24 | 11 | Q4160 | 00857877005429 |
| NO-1350 | 3.5x3.5cm | 12.25 | 13 | Q4160 | 00618474000572 |
| NO-1440 | 4x4cm | 16 | 16 | Q4160 | 00857877005054 |
| NO-1450 | 4.5x4.5cm | 20.25 | 21 | Q4160 | 00618474000589 |
| NO-1650 | 6.5x6.5cm | 42.25 | 43 | Q4160 | 00618474000596 |
Please refer to the NuShield instructions for use for usage and safety information.
Data on File, Organogenesis Inc. Supporting information available upon request.