Small intestinal submucosa wound matrix and full-thickness venous ulcers: Preliminary results

Recently developed wound care biomaterials derived from natural tissue sources have been shown to improve wound closure by stimulating granulation tissue deposition and epithelization of dermal wounds. These products may offer significant advantages to other available treatments for the management of venous ulcers. One such biomaterial, derived from porcine small intestinal submucosa (SIS), has shown promise as an effective treatment to manage full-thickness wounds. This is an interim analysis of a prospective, randomized, controlled, clinical trial currently being conducted to examine the effectiveness of SIS wound matrix in treating full-thickness venous leg ulcers. Patients meeting inclusion criteria were randomized to either receive treatment with the SIS wound matrix or a standard of care therapy. Ulcer size was determined at enrollment and weekly throughout treatment. Healing, as defined by full epithelization, was assessed at each visit for a period of up to 12 weeks. Complete wound closure within 12 weeks is the primary outcome measure. In this interim analysis, the authors include results from the first 84 evaluable patients enrolled in the trial. The authors found 71 percent of venous ulcers healing at 12 weeks with SIS compared to 46 percent with standard care, a significant group difference. The authors conclude that, in this subset of patients, the SIS wound matrix showed a higher incidence of wound closure as compared to standard of care treatment.