RESPOND REGISTRY—INTERIM ANALYSIS

The Real-World Effectiveness Study of PuraPly® AM on Wounds (RESPOND) shows how PuraPly AM is proven to improve healing trajectories in a variety of chronic wounds.1 This interim analysis included patients with final results as of January 26, 2018.

OBJECTIVE

Prospective observational study to assess the effectiveness of PuraPly AM in real-world clinical settings, as measured by percent reduction in wound area, time to complete wound closure, and improvement in wound bed condition.

STUDY DESIGN

  • Post-marketing, open-label, prospective, observational multicenter study (NCT03286452)
  • Patients received standard of care in addition to PuraPly AM
  • Wounds were cleaned and prepared with debridement at initial visit
  • PuraPly AM was applied at week 0 and weekly thereafter
  • At each visit, wounds were assessed for wound characteristics, wound area & depth, and quality of granulation tissue

STUDY SUBJECTS

  • N=63
  • Mean wound area at baseline: 6.5 cm2
  • Mean wound duration at baseline: 4 months
SEE BASELINE 
CHARACTERISTICS

RESULTS

  • 57/63 (90%) of wounds had a reduced wound area over the 4-month interim analysis
  • 43/63 (68.3%) achieved complete wound closure with a mean time to wound closure of 5 weeks
  • In the wounds that did not achieve complete closure, 14 decreased in wound area by an average of 54.1%
  • Two adverse events of worsening infection and worsening wound appearance were reported during the study. Both were considered mild and not attributed to PuraPly AM
The chronic wound types studied and their percentage of wound closure over 12 weeks in the RESPOND registry interim analysis

Healing trajectory of various wound types. Wound closure rates over time show an increase in the percentage of wounds achieving closure from the beginning of the study through Week 12. All wound types, except for chronic vascular wounds, exhibited some wound closure throughout the study.

SUPPORTING HEALING IN STALLED WOUNDS

See how PuraPly AM supported healing in chronic wounds that failed ~2 years of prior therapies, or contact an Organogenesis Tissue Regeneration Specialist to see how PuraPly AM can help your practice.

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REFERENCE:

  1. Bain MA, et al. Plast Reconstr Surg Glob Open. 2019;7(6):e2251.