General Medicine: Open Access

ISSN - 2327-5146


Retrospective Cohort Study Evaluating Clinical Outcomes in Lower Extremity Ulcers Treated with a Bi-layered Bioengineered Skin Substitute (BBSS) as Compared to Standard Therapy

Min Yao, Latricia Allen, Kirsti Diehl, Michael French, Nanjin Park and Vickie R Driver

Purpose/Background: The purpose of this retrospective cohort study was to evaluate the efficacy of a bi-layered bioengineered skin substitute (BBSS) on wound healing in patients with chronic lower extremity ulcers (LEUs) and multiple co-morbidities such as diabetes with neuropathy, hypertension, cardiovascular, chronic kidney disease, peripheral vascular disease, critical limb ischemia and venous disease. Methods: A retrospective cohort study was conducted using the Boston University Medical Center electronic medical record and clinical warehouse data. Co-morbidities such as hypertension, coronary heart disease, cerebrovascular disease, peripheral arterial disease, chronic renal disease, congestive heart failure, and history of minor and major amputation were examined to assess any correlation with wound healing. Results: 158 BBSS and 126 control patients with LEUs were included in this cohort study with a follow-up period of 180 days. More ulcers healed in the BBSS group than in the control group. The rate for complete wound closure was 69.84% in BBSS and 41.98% in the control (P<0.05). Average time to achieve wound closure was 70.1 days in the BBSS group and 118.03 days in the control group (P<0.05). The BBSS group was1.69 times (95% CI=1.14-2.73) more likely to have their wound healed as compared to the control patients. Conclusion: BBSS may be useful in accelerating wound healing in patients with severe LEUs.