An interventional study of Amnioeffect in Thyroid; Wound, Parathyroid Diseases and Surgical Incision, sponsored by Sarasota Memorial Health Care System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Sarasota Memorial Health Care System · Not applicable, Interventional, and Treatment
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.
365 studies on the registry are indexed under Thyroid Diseases; 80 are open to participants now.
This study's planned enrollment of 334 is above the median of 88 across 198 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Sarasota Memorial Health Care System is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.
Other: Amnioeffect
No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
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.
Time frame: Pre-procedure, 1 month post procedure, 3 months post procedure
Determine swallowing effectiveness
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.
Time frame: 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.
Time frame: Pre-procedure, 1 month post procedure, 3 months post procedure
Plan to share: No
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Sarasota Memorial Health Care System