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

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

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.

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.

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