Incision, Parathyroid Diseases, Surgical Incision, Thyroid; Wound
Conditions
Keywords
thyroid, parathyroid, surgery
Brief summary
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.
Detailed 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.
Interventions
OTHERAmnioeffect
Amnioeffect is a placental-based allograft made of lyophilized human amnion/intermediate/chorion membrane (LHACM)
Sponsors
Sarasota Memorial Health Care System
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of scar appearance | Pre-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 effectiveness | Pre-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 Score | Pre-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. |
Countries
United States
Outcome results
None listed