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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Sarasota Memorial Health Care System
Study ID
NCT07173621
Status
Enrolling By Invitation

Conditions

  • Incision
  • Parathyroid Diseases
  • Surgical Incision
  • Thyroid; Wound

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2025
Completion
Oct 1, 2027

Study Design

Enrollment
334 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amnioeffect Application
    AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.
  • No Intervention: No Amnioeffect Application
    No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated

Primary Outcome Measure

Improvement of scar appearance [ Time Frame: Pre-procedure, 1 month post procedure, 3 months post procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarasota Memorial Health Care SystemSarasotaFlorida34239-

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Sarasota Memorial Health Care System· Sarasota, FL

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