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.
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
- Conditions the study is for
- Thyroid; Wound, Parathyroid Diseases, Surgical Incision
- 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
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.)
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- 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
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.
- Conditions
- Thyroid; Wound, Parathyroid Diseases, Surgical Incision, Incision
- 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 group | Role | What they receive |
|---|---|---|
| Amnioeffect Application | Experimental | AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated. Receives: Other: Amnioeffect |
| No Amnioeffect Application | No intervention | No 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.
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
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
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.
- First posted15 Sep 2025
- Study start24 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thyroid; WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sarasota Memorial Health Care System
- Sponsor type
- University, hospital or other
- Collaborators
- MiMedx Group, Inc.
- Responsible party
- Principal investigator, Ralph Tufano, Sarasota Memorial Health Care System
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 34256121Watt 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 25004246Sonbol 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 30221137Koob 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 25176107Joshi 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 32580594Dean 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 19041821Cheng 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