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Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in Patients Who Have Undergone Thyroid and Parathyroid Surgery Via the Transcutaneous Approach
Sponsor: Sarasota Memorial Health Care System
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2025-10-01
Completion Date
2027-10-01
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
Amnioeffect
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
Locations (1)
Sarasota Memorial Health Care System
Sarasota, Florida, United States