Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment

Abstract

Collagen/oxidized regenerated cellulose (ORC)/silver therapy has been designed to facilitate wound healing by normalizing the microenvironment and correcting biochemical imbalances in chronic wounds. The aim of this study was to compare collagen/ORC/silver therapy to control (standard treatment). Patients with diabetic foot ulcers were randomized to either collagen/ORC/silver (24) or control treatment (15). Wound area measurements and wound fluid samples were taken weekly. Protease levels were measured in wound fluid samples to investigate differences between responders (≥50% reduction in wound area by week 4) and nonresponders (<50% reduction in wound area by week 4). There were significantly more responders in the collagen/ORC/silver group compared with the control group (79% vs. 43%, p = 0.035). There were significantly fewer withdrawals from the study because of infection in the collagen/ORC/silver group compared with the control group (0% vs. 31%, p = 0.012). The sum of matrix metalloproteinase-9 and elastase concentration was higher in nonresponders compared with responders at baseline (p = 0.0705) and week 4 (p = 0.012). The results suggest that collagen/ORC/silver normalizes the wound microenvironment and protects against infection, resulting in improved wound healing. It was also demonstrated that measuring a combination of proteases may be a more relevant prognostic healing marker than any individual protease alone.

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

“…However, due to its acidic pH, ORC is resistant to bacterial infection,24 and several studies have found that ORC actually prevents infection 2526. In the current study, none of the animals exhibited significant preoperative to postoperative changes in WBC and CRP values, the presence of which may suggest infection.…”

Topical Collagen-Based Biomaterials for Chronic Wounds: Rationale and Clinical Application

“…70 Clinical studies have shown a significant reduction of MMP, elastase, and gelatinase content in diabetic foot ulcers with either ORC/collagen or ORC/collagen/silver. 73,74 Although not proof of cause and effect, when combined with the evidence that elevated inflammatory protease activity in the wound is a robust indicator of nonhealing, 75 the portfolio of studies strongly supports the fact that ORC/ collagen will modulate the chronic wound microenvironment.…”

The Effectiveness of Negative Pressure Therapy in Diabetic Foot Ulcers with Elevated Protease Activity: A Case Series

“…Oxidized regenerated cellulose/collagen matrix (ORC/collagen matrix) has been reported to improve the wound microenvironment by adsorbing wound exudate and retaining proteases within the dressing structure. [7][8][9][10][11][12][13] A randomized controlled trial demonstrated the superiority on modulating proteases of a wound dressing based on the LipidoColloid Technology, impregnated with a NanoOligo Saccharide Factor compared with an ORC/ collagen matrix. 14 A systematic review of the clinical evidence on protease-modulating dressing and researches that compare these devices would be useful in providing an overview of the appropriate treatment to achieve optimal healing for chronic wounds.…”

“…[7][8][9][10][11][12][13][14] Among these, negative pressure therapy (NPT) plays an interesting role. NPT is a noninvasive therapy system that applies controlled negative pressure using a vacuum-assisted closure device.…”