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

Sarasota Memorial Health Care System

Status

Invitation-only

Conditions

Incision

Surgical Incision

Thyroid; Wound

Parathyroid Diseases

Treatments

Other: Amnioeffect

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07173621

25-SURG-34

Details and patient eligibility

About

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.

Full 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.

Enrollment

334 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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