The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16‐week pilot study

Abstract

A prospective, single-centre, randomized controlled study was performed to evaluate the effectiveness of Graftjacket, a human acellular regenerative tissue matrix as a treatment option for chronic non healing lower extremity wounds. Twenty-eight diabetic patients with full-thickness wounds that had been present for at least 6 weeks were treated with sharp debridement and randomized to a single application of Graftjacket tissue matrix plus mineral oil-soaked fluff compression dressing or to a control treatment of wound gel with gauze dressings. All patients were seen weekly. By week 16, 12 of 14 patients treated with Graftjacket tissue matrix demonstrated complete wound closure compared with 4 of 14 patients in the control group. Patients treated with Graftjacket tissue matrix showed a statistically significant higher percentage of wound healing with respect to wound area, and clinically significant differences in wound depth and wound volume. This comparison is not performed to demonstrate that the application of the Grafjacket is more effective than sharp debridement. This study is done to help assign a role to the use of Graftjacket matrix in lower extremity wound care.

Quantification of DNA in Biologic Scaffold Materials

“…Despite the presence of DNA in many of the commercially available ECM devices, the clinical efficacy of these devices for their intended application has been largely positive [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. It therefore appears unlikely that the remaining DNA fragments within these biological scaffold materials contribute to any adverse host response or are a cause for concern.…”

“…Decellularization is considered important because of the potential adverse immune response elicited by cell membrane epitopes, allogeneic or xenogeneic DNA, and damageassociated molecular pattern molecules [15][16][17]. Despite the broad clinical success of ECM scaffolds [1][2][3][4][5][6][7][8][9][10][11][12][13][14], porcine DNA remnants have been implicated as the cause of "inflammatory reactions" following the implantation of porcine derived scaffolds for orthopedic applications [18]. Several commercially available ECM scaffold materials, in particular Restore (porcine small intestinal submucosa [SIS]), GraftJacket (human dermis), and TissueMend (bovine dermis), have been shown to contain trace amounts of DNA [18,19].…”

“…Biological scaffold materials composed of mammalian extracellular matrix (ECM) are commonly used for the surgical repair and reconstruction of musculotendinous, dermal, cardiovascular, gastrointestinal, and lower urinary tract tissues, among others [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. These ECM scaffolds are harvested from a variety of tissues including porcine dermis, small intestine, and urinary bladder, bovine dermis, equine pericardium, and human dermis.…”

A review of tissue-engineered skin bioconstructs available for skin reconstruction

“…GraftJacket is a similar product, 0.4 -0.8 mm thick, pre-meshed for the convenience of application, often used for tendon (Valentin et al 2006;Furukawa et al 2007) and low extremity wounds repair (Brigido 2006). Successful treatment of superficial and deep wounds has been reported (Kim et al 2006) but information regarding thermal injuries treatment is limited because of the novelty of this biomaterial.…”

The Role of Acellular Flowable Matrix in Tissue Regeneration

“…Cellular and acellular bioengineered grafts have demonstrated some promise as alternatives for the treatment of such wounds. [14,15,16,17] However, these grafts are provided as sheets in planar form. As such, they are harder to use and less effective in sinus tract wounds because of the irregularly shaped tunnels or extensions in these wounds.…”