In response:
We would like to thank Dr Keller for his thoughtful comments regarding the February 2007 article, "The Edge Effect: Current Therapeutic Options to Advance the Wound Edge." Based on information from the original monograph, Apligraf was recommended for application within 5 days of delivery. We are delighted to be made aware that this bilayered skin substitute is viable for application 10 days from shipment.
The purpose of Table 2 on page 102 was to highlight some of the available advanced therapies and their supporting scientific evidence. We identified several randomized controlled trials that demonstrated significant accelerated wound closure with the use of Apligraf in the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). We congratulate Organogenesis for its commitment to generating high-quality clinical studies for informed practice. In his letter, Dr Keller reminded the reader that Apligraf is FDA-approved for the treatment of both DFUs and VLUs. We agree that other products have not undergone FDA review of clinical data from randomized clinical trials. Again, our intention was to summarize key literature that supports the use of these therapies.
The science of wound healing will continue to evolve based on emerging evidence. As clinicians, we need to determine the maximum benefit to our patients by critically examining the literature and synthesizing the information with expert opinion and patient preference.
Kevin Woo, MSc, RN, PhD(C), ACNP, GNC(C)
Elizabeth A. Ayello, PhD, RN, APRN,BC, CWOCN, FAPWCA, FAAN
R. Gary Sibbald, BSc, MD, FRCPC (Med) (Derm), FAPWCA, MEd