A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management

Abstract

Advances in tissue preservation have led to the commercialization of human placental membranes for the purposes of wound management with each product being characterized by different compositions and properties. The a priori specification of the research question in this investigator‐initiated study focused on the clinical outcomes in two nonrandomized, however statistically equal and homogenous patient cohorts receiving either a viable intact cryopreserved human placental membrane (vCPM) or a dehydrated human amnion/chorion membrane (dHACM), for the management of wounds at a single center. A total of 79 patients with 101 wounds were analyzed: 40 patients with 46 wounds received vCPM and 39 patients with 55 wounds received dHACM. The proportion of wounds achieving complete wound closure was 63.0% (29/46) for vCPM and 18.2% (10/55) for dHACM (p < 0.0001) for all treated wounds combined. This is the first comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting.

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

“…Clinical outcomes of vCPM have been reported in multiple studies for wounds of various etiologies and locations. [12][13][14][15][16][17][18][19][20] In the present study using vLPM adjunct to SOC, we demonstrated similar closure rates to those rates previously shown in clinical studies with the cryopreserved formulation (Fig. 2).…”

“…[8][9][10][11] High closure rates for difficult-to-treat wounds of different etiologies and locations have been demonstrated in multiple vCPM clinical studies. [12][13][14][15][16][17][18][19][20] Two prospective studies, one utilizing amnionderived vCPM and one utilizing chorion-derived vCPM, demonstrated a 62% and 59.3% closure rate for chronic diabetic foot ulcers (DFUs) and chronic complex DFUs, respectively. 12,14 Results of these DFU prospective clinical trials are mirrored by reported DFU closure rates in real-world patients.…”

“…[18][19][20] In two retrospective studies, various types of wounds managed with vCPM plus SOC showed closure rates of 76.1% and 63.0%, respectively. 13,15 In a prospective, single-arm study, 53.0% of patients achieved complete wound closure with vCPM plus SOC in the treatment of chronic venous leg ulcers (VLUs) that had previously failed 12 weeks of SOC. 17 All these studies show similar closure rates for wounds of various etiologies and locations that have been managed with either amnion-or chorion-derived vCPM adjunct to SOC.…”

Immunomodulatory Effects of Human Cryopreserved Viable Amniotic Membrane in a Pro-Inflammatory Environment In Vitro

“…In a recent study, a novel comparative effectiveness research technique was used to perform a retrospective non-randomized investigation to compare clinical trial data from chronic wound patients treated with hCVAM or a dehydrated-hAM. 8,20 The results showed that wounds treated with hCVAM closed at a significantly higher rate (63%) than those treated with the dehydrated membrane (18.2%) over 12 weeks. 20 Additionally, in vitro studies showed that hCVAM released lower levels of profibrotic transforming growth factor- β 1 (TGFB1), as well as decreased levels of pro-inflammatory factors including interferon- γ (IFNG), chemokine (C–C motif) ligand 5 (CCL5), epidermal growth factor (EGF), and thrombopoietin, compared to devitalized hAM.…”

“…8,20 The results showed that wounds treated with hCVAM closed at a significantly higher rate (63%) than those treated with the dehydrated membrane (18.2%) over 12 weeks. 20 Additionally, in vitro studies showed that hCVAM released lower levels of profibrotic transforming growth factor- β 1 (TGFB1), as well as decreased levels of pro-inflammatory factors including interferon- γ (IFNG), chemokine (C–C motif) ligand 5 (CCL5), epidermal growth factor (EGF), and thrombopoietin, compared to devitalized hAM. 56 On the other hand, hAM-derived ECM itself has been shown to promote enhanced cell proliferation compared to intact hCVAM.…”