Abstract
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.
Highlights
Ulcers or open wounds of the lower extremity are a major health problem that can significantly decrease patient quality of life, often leading to prolonged hospitalization and amputation [1]
Extremity Ulcers Treated with a Bi-layered Bioengineered Skin Substitute (BBSS) as Compared to Standard Therapy
There were 126 patients treated with BBSS and 162 in the control group
Summary
Ulcers or open wounds of the lower extremity are a major health problem that can significantly decrease patient quality of life, often leading to prolonged hospitalization and amputation [1]. BBSS have been used in recent years to treat complicated non-healing diabetic and venous stasis ulcers. BBSS has been reported as being able to promoting wound healing and prevent complications in LEUs via randomized clinical trials (RCTs) [3,4,5]. RCT proven therapies may fail to be effective in clinically complex patients. This might be attributed to RCT designs that do not reflect the complex issues faced in clinical practice and are limited by the challenges of designing such studies given wound heterogeneity. Use of practice based evidence (PBE) and observational study data can provide important clinical insights that are generally missing from RCTs [7,8,9,10]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.