Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in … (NCT07173621) | Clinical Trial Compass
By InvitationNot Applicable
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
United States334 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of scar appearance
Timeframe: Pre-procedure, 1 month post procedure, 3 months post procedure
2
Determine swallowing effectiveness
Timeframe: Pre-procedure, 1 month post procedure, 3 months post procedure
3
Improvement in Pain Score
Timeframe: Pre-procedure, 1 month post procedure, 3 months post procedure