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| Name | Class |
|---|---|
| MiMedx Group, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amnioeffect Application | Experimental | AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated. |
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| No Amnioeffect Application | No Intervention | No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnioeffect | Other | Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-procedure, 1 month post procedure, 3 months post procedure |
| Determine swallowing effectiveness | Measured by use of the SWAL-QOL 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. | 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. | Pre-procedure, 1 month post procedure, 3 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarasota Memorial Health Care System | Sarasota | Florida | 34239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34256121 | Background | Yilmaz S, Habibi HA, Yildiz A, Altunbas H. Thyroid Embolization for Nonsurgical Treatment of Nodular Goiter: A Single-Center Experience in 56 Consecutive Patients. J Vasc Interv Radiol. 2021 Oct;32(10):1449-1456. doi: 10.1016/j.jvir.2021.06.025. Epub 2021 Jul 10. | |
| 25004246 | Background | Watt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8. |
| Label | URL |
|---|---|
| AMNIOEFFECT PRODUCT BROCHURE | View source |
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During the study, 334 patients who are to undergo transcutaneous thyroid or parathyroid surgery will be recruited to participate over a one-year period. A sample size of approximately 300 patients (150 per group), assuming a drop-out rate of 10%, a total sample size of 334 will be enrolled. 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.
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| 30221137 | Background | Sonbol HS. Extracellular Matrix Remodeling in Human Disease. J Microsc Ultrastruct. 2018 Jul-Sep;6(3):123-128. doi: 10.4103/JMAU.JMAU_4_18. |
| 25176107 | Background | Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40. doi: 10.1002/jbm.b.33265. Epub 2014 Aug 30. |
| 32580594 | Background | Joshi CJ, Hassan A, Carabano M, Galiano RD. Up-to-date role of the dehydrated human amnion/chorion membrane (AMNIOFIX) for wound healing. Expert Opin Biol Ther. 2020 Oct;20(10):1125-1131. doi: 10.1080/14712598.2020.1787979. Epub 2020 Jul 20. |
| 19041821 | Background | Dean DS, Gharib H. Epidemiology of thyroid nodules. Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):901-11. doi: 10.1016/j.beem.2008.09.019. |
| 37581037 | Background | Cheng KL, Liang KW, Lee HL, Wang HY, Shen CY. Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach. Quant Imaging Med Surg. 2023 Aug 1;13(8):5355-5361. doi: 10.21037/qims-22-1385. Epub 2023 May 30. |
| AMNIOEFFECT Application Guide | View source |
| Processing | View source |
| Spine and Neurosurgery | View source |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D014947 | Wounds and Injuries |
| D010279 | Parathyroid Diseases |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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