Sarasota Memorial Health Care System
The purpose of this study is to understand how placing Amnioeffect on patients having transcutaneous thyroid or parathyroid surgery affects surgery scar appearance, pain, and the ability to swallow and compare it to patients who do not have anything placed during surgery. The Food and Drug Administration regulates the use of Amnioeffect for homologous use. Both Amnioeffect application and no Amnioeffect application are considered standard of care; however, for the purpose of this study, the use of Amnioeffect during surgery will be considered the intervention, and no Amnioeffect application will be the standard of care.
A product called AMNIOEFFECT has been developed as a barrier intended for use in the treatment of acute and chronic wounds, providing a protective environment to support the healing process. Manufactured by the company MIMEDX, it is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM). During the study, 334 patients who are to undergo transcutaneous thyroid or parathyroid surgery will be recruited to participate over a one-year period. Using a randomized control approach, the study would be conducted to evaluate the impact of AMNIOEFFECT placed ove…
Inclusion Criteria: * Adults 18 years or older * Patients undergoing thyroid/parathyroid surgery via a transcutaneous incision * Participants must be willing and able to consent and take part in the study Exclusion Criteria: * Patients \< 18 years old * Pregnant patients * Patients with a history of keloid scarring * Patients who refuse blood products * Previous neck surgery * Patients on immunosuppressive medications (steroids, immune modulators, etc.) * Patients with a known sensitivity to aminoglycoside antibiotics * Patients with an active or latent infection * Patients with a disorder…
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
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