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NCT07173621

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Sarasota Memorial Health Care System
~334 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Amnioeffect

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement of scar appearance
Measured over Pre-procedure, 1 month post procedure, 3 months post procedure
+2 more outcomes measured

Conditions

Thyroid; Wound
Parathyroid Diseases
Surgical Incision
Incision

Explore related trials

Parathyroid Gland DisorderThyroid Gland Disorder

Where it's being run

1 sites across 1 states
Florida1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Improvement of scar appearancePre-procedure, 1 month post procedure, 3 months post procedure

    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.

  • Determine swallowing effectivenessPre-procedure, 1 month post procedure, 3 months post procedure

    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.

  • Improvement in Pain ScorePre-procedure, 1 month post procedure, 3 months post procedure

    Measured by use of the Visual Analog Scale; scoring 0 for no pain-10 for unbearable pain.