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

NCT07173621 | Enrolling By Invitation

• 1 other identifier: 25-SURG-34
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Thyroid; Wound; Parathyroid Diseases; Surgical Incision; Incision

Keywords

thyroid; parathyroid; surgery

Outcome Measures

Primary Outcomes (3)

• 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.

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

• Determine swallowing effectiveness

  Measured by use of the SWAL-QOL 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.

  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.

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

Study Arms (2)

Amnioeffect Application

EXPERIMENTAL

AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.

Other: Amnioeffect

No Amnioeffect Application

NO INTERVENTION

No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated

Interventions

Amnioeffect OTHER

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

Amnioeffect Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarasota Memorial Health Care System: lead
• MiMedx Group, Inc.: collaborator

Study Sites (1)

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Related Publications (7)

• 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.

  PMID: 34256121 BACKGROUND

• 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.

  PMID: 25004246 BACKGROUND

• 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.

  PMID: 30221137 BACKGROUND

• 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.

  PMID: 25176107 BACKGROUND

• 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.

  PMID: 32580594 BACKGROUND

• 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.

  PMID: 19041821 BACKGROUND

• 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.

  PMID: 37581037 BACKGROUND

Related Links

• AMNIOEFFECT PRODUCT BROCHURE
• AMNIOEFFECT Application Guide
• Processing
• Spine and Neurosurgery

MeSH Terms

Conditions

Thyroid Diseases; Wounds and Injuries; Parathyroid Diseases; Surgical Wound

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)