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Thyroid; WoundNCT07173621

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

A study testing Amnioeffect in people with Thyroid; Wound and Parathyroid Diseases, run by Sarasota Memorial Health Care System at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Amnioeffect
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteUnited States
Study dates
24 Nov 2025to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

Other trials in United States

About this study

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.

Read the 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. 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 over the strap muscle closure before the subcutaneous tissues and skin are reapproximated, compared to standard of care on post-operative pain, swallowing ability, and cosmesis (conferring of beauty) as indicated by scar appearance.

Being tested
Amnioeffect
Keywords
thyroid, parathyroid, surgery
Medical subject headings
Thyroid Diseases, Wounds and Injuries, Parathyroid Diseases, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmnioeffectOther

    Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)

Study groups in NCT07173621
Study groupRoleWhat they receive
Amnioeffect ApplicationExperimentalAMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.
Receives: Other: Amnioeffect
No Amnioeffect ApplicationNo interventionNo AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of scar appearance

    Measured by use of the Vancouver Scar Scale; scores rating on vascularity, pigmentation, pliability, and height. Total score ranges from 0-13, with 0 being "normal" appearance.

    Measured: Pre-procedure, 1 month post procedure, 3 months post procedure

  2. Determine swallowing effectiveness

    Measured by use of the SWAL-QOL (Swallowing Quality of Life) score; this survey uses a Likert scale rating to ask questions regarding swallowing difficulties and associated quality of life impacts. Higher scores reflect lower impact on quality of life; lower scores would indicate higher impact.

    Measured: Pre-procedure, 1 month post procedure, 3 months post procedure

  3. Improvement in Pain Score

    Measured by use of the Visual Analog Scale; scoring 0 for no pain-10 for unbearable pain.

    Measured: Pre-procedure, 1 month post procedure, 3 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start24 Nov 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
During the study, 334 patients who are to undergo transcutaneous thyroid or parathyroid surgery will be recruited to participate over a one-year period. A sample size of approximately 300 patients (150 per group), assuming a drop-out rate of 10%, a total sample size of 334 will be enrolled. Using a randomized control approach, the study would be conducted to evaluate the impact of AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated, compared to standard of care on post-operative pain, swallowing ability, and cosmesis (conferring of beauty) as indicated by scar appearance.
Masking
None (open label)
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07173621
Sponsor's protocol ID
25-SURG-34
Status last verified
Sep 2025
First submitted
7 Sep 2025
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yilmaz S, Habibi HA, Yildiz A, Altunbas H. Thyroid Embolization for Nonsurgical Treatment of Nodular Goiter: A Single-Center Experience in 56 Consecutive Patients. J Vasc Interv Radiol. 2021 Oct;32(10):1449-1456. doi: 10.1016/j.jvir.2021.06.025. Epub 2021 Jul 10.

    PubMed 34256121

  • Watt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8.

    PubMed 25004246

  • Sonbol HS. Extracellular Matrix Remodeling in Human Disease. J Microsc Ultrastruct. 2018 Jul-Sep;6(3):123-128. doi: 10.4103/JMAU.JMAU_4_18.

    PubMed 30221137

  • Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40. doi: 10.1002/jbm.b.33265. Epub 2014 Aug 30.

    PubMed 25176107

  • Joshi CJ, Hassan A, Carabano M, Galiano RD. Up-to-date role of the dehydrated human amnion/chorion membrane (AMNIOFIX) for wound healing. Expert Opin Biol Ther. 2020 Oct;20(10):1125-1131. doi: 10.1080/14712598.2020.1787979. Epub 2020 Jul 20.

    PubMed 32580594

  • Dean DS, Gharib H. Epidemiology of thyroid nodules. Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):901-11. doi: 10.1016/j.beem.2008.09.019.

    PubMed 19041821

  • Cheng KL, Liang KW, Lee HL, Wang HY, Shen CY. Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach. Quant Imaging Med Surg. 2023 Aug 1;13(8):5355-5361. doi: 10.21037/qims-22-1385. Epub 2023 May 30.

    PubMed 37581037

Questions about this trial

What is this clinical trial studying?

A study testing Amnioeffect in people with Thyroid; Wound and Parathyroid Diseases, run by Sarasota Memorial Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of scar appearance (time frame: Pre-procedure, 1 month post procedure, 3 months post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07173621, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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