NEW CASE STUDIES: SEE HOW AFFINITY® HELPED TO SUPPORT WOUND MANAGEMENT

RCT and real-
world evidence

As a protective barrier and ECM scaffold, Affinity® was proven to support wound management in a prospective, multicenter, randomized controlled trial (RCT)1

  • Assessed efficacy of Affinity vs standard of care (SOC)* in 76 patients with refractory diabetic foot ulcers (DFUs) (>4 weeks' duration)
  • Digital planimetry† accurately captured DFU area, depth, and volume
  • When Affinity was used as a protective barrier as part of the course of wound management, the incidence and time to wound closure were significantly improved (both P<0.05)

When Affinity was used as a protective barrier as part of the course of wound management, significantly more DFUs were closed than with SOC at 8, 12 and 16 weeks (P=0.04)1

Frequency of wound closure‡

36% DFUs closed at 8 weeks with Affinity vs 23% with SOC. 60% DFUs closed at 12 weeks with Affinity vs 38% with SOC. 63% DFUs closed at 16 weeks with Affinity vs 38% with SOC.

*Debridement, infection elimination, dressings, and offloading by total contact casting. †Silhouette® laser-assisted wound measurement device. ‡Estimated frequency of wound closure at weeks 8, 12 and 16; estimated from Cox adjusted survival data for wound closure.

Median time to DFU closure with Affinity used as a protective barrier was 11 weeks. SOC failed to attain this endpoint at 16 weeks.1

When Affinity was used as a protective barrier as part of the course of wound management, significantly more DFUs achieved >60% reduction in wound area (P=0.02) and depth (P=0.04) and >75% reduction in volume (P=0.06) than with SOC1

82% DFUs achieved >60% reduction in wound area vs 58% with SOC. 81% DFUs achieved >75% reduction in volume vs 58% with SOC.

*Debridement, infection elimination, dressings, and offloading by total contact casting. †Silhouette® laser-assisted wound measurement device.

Real-world evidence

Affinity has been used as a protective barrier in a wide variety of wounds from head to toe.2-4

≥65%
Wound size reduction at 3 weeks when Affinity was used as a protective barrier as part of the course of wound management
Study author: Lambert • Study type: retrospective case series • Wound types: mixed (N=6 wounds)
93.9%
Wound size reduction at 6 weeks when Affinity was used as a protective barrier as part of the course of wound management
Study author: Sabo • Study type: prospective case series • Wound types: mixed (N=3 wounds)
100%
Of wounds closed at 9 weeks when Affinity was used as a protective barrier as part of the course of wound management
Study author: Carpenter • Study type: retrospective case series • Wound types: mixed (N=5 wounds)

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Please refer to the Affinity instructions for use for usage and safety information.

REFERENCES:

  1. Serena TE, et al. J Comp Eff Res. 2019. doi:10.2217/cer-2019-0142
  2. Lambert et al. Presented at: Symposium on Advanced Wound Care Fall 2015; September 26-28, 2015; Las Vegas, NV.
  3. Sabo M, et al. Chronic Wound Care Manage Res. 2018;5:1-4.
  4. Carpenter et al. Presented at: 4th Annual Innovations in Wound Healing Conference; December 7-10, 2017; Bimini, Bahamas.