Potential Risks to Study Patients Clause Samples

Potential Risks to Study Patients. ‌ MIRODERM wound matrix is a cleared wound care product and will be used in accordance with approved indications and instructions for use (K140510 and K143426). As an observational, post-market study of a commercialized device for approved indications, the risk to a patient participating in this study is not fundamentally different than the risks this patent would encounter undergoing treatment with a porcine derived biologic wound matrix and not participating in this study. Thus, the only risk unique to this study would be inadvertent disclosure of protected health information. There are risks, not directly associated with study participation, associated with treatment which may include but are not limited to: • Sensitivity or allergic reaction to porcine material • Infection • Additional tissue damage during sharp debridement • Cellulitis • Osteomyelitis