Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
Sarasota Memorial Health Care System
Collaborating Sponsors:
MiMedx Group, Inc.
Conditions:
Thyroid; Wound
Parathyroid Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 an...
Detailed Description
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. Manufactu...
Eligibility Criteria
Inclusion
- 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
- 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 that would create an unacceptable risk of post-operative complications
- Subjects may be excluded at the discretion of the physician(s) based on their clinical judgment and/or if the health or safety of the participant may be potentially impacted by taking part in this study
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT07173621
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239