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.
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.
- 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
- Mean wound area at baseline: 6.5 cm2
- Mean wound duration at baseline: 4 months
- 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
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.
- Bain MA, et al. Plast Reconstr Surg Glob Open. 2019;7(6):e2251.