Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2025-10-01 -> 2027-11-01 2026-08-04
minor Completion pushed: 2027-10-01 -> 2027-12-01 2026-08-04
Trial Details
NCT Number NCT07173621
Lead Sponsor Sarasota Memorial Health Care System
Collaborators: MiMedx Group, Inc.
Conditions Thyroid; Wound, Parathyroid Diseases, Surgical Incision, Incision
Enrollment 334 participants
Start Date 2025-11-24
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-03