WoundReference improves clinical decisions
 Choose the role that best describes you
Ananian CE, Dhillon YS, Van Gils CC, Lindsey DC, Otto RJ, Dove CR, Pierce JT, Saunders MC, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 2018 May 1;volume 26(3):274-283.
1. Wound Repair Regen. 2018 May;26(3):274-283. doi: 10.1111/wrr.12645. Epub 2018 Aug 27. A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers. Ananian CE(1), Dhillon YS(2), Van Gils CC(3), Lindsey DC(4), Otto RJ(5), Dove CR(6), Pierce JT(7), Saunders MC(8). Author information: (1)New Hope Podiatry, Los Angeles, California, 90063, USA. (2)Banner University Medical Center, Phoenix, Arizona, 85006, USA. (3)Foot & Ankle Institute, St. George, Utah 84770, USA. (4)CHRISTUS St. Vincent Regional Wound and Hyperbaric Center, Santa Fe, New Mexico 87505, USA. (5)St. Luke's Clinic - Wound and Hyperbarics, Meridian, Idaho 83642, USA. (6)Advanced Foot & Ankle Center, Las Vegas, Nevada 89119, USA. (7)Virginia Mason Medical Center, Federal Way, Washington 98003, USA. (8)Osiris Therapeutics, Inc., Columbia, Maryland 21046, USA. Randomized controlled clinical trials, the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers in comparison to standard of care. However, randomized controlled clinical trials comparing efficacy between two or more skin substitutes are very limited. With growing numbers of new skin substitutes, such studies are essential for treatment and policy-making decisions by wound care providers and payers. In this study, we analyzed clinical outcomes and product cost between a viable cryopreserved placental membrane (vCPM) and a human fibroblast-derived dermal substitute (hFDS) for the treatment of chronic diabetic foot ulcers in a prospective, multicenter, single-blind study. The outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group and 31 patients in the hFDS treatment group. Utilizing a non-inferiority trial design and the established treatment regimen of 8 applications for hFDS, we demonstrated that vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% CI: [10.67, 28.94]). However, preliminary findings show that vCPM may have better outcomes for wounds ≤ 5 cm2 : 81.3% (13/16) of wounds in the vCPM group vs. 37.5% (6/16) of wounds in the hFDS group reached complete closure at the end of treatment (p = 0.0118). A preliminary product cost analysis for wounds ≤ 5 cm2 may show significant savings for patients treated with vCPM. Average per-patient costs during the course of treatment were $3,846 and $7,968 (p < 0.0001) for vCPM and hFDS patients, respectively. These results may be used as guidance to wound care providers and payers. © 2018 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society. DOI: 10.1111/wrr.12645 PMID: 30098272 [Indexed for MEDLINE]
Appears in following Topics:
Cellular and/or Tissue Based Products
Diabetic Foot Ulcer - Treatment
Cellular and/or Tissue Based Products