Amnioeffect for Post-Operative Healing in Thyroid and Parathyroid Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how Amnioeffect, a treatment applied to the surgery site, might aid healing after thyroid or parathyroid surgery. Researchers aim to determine if applying Amnioeffect can improve scar appearance, reduce pain, and ease swallowing compared to no additional treatment. The study includes two groups: one receives Amnioeffect, and the other does not. It seeks adults scheduled for these surgeries who are willing to participate. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially enhance post-surgery recovery for future patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on immunosuppressive medications, you cannot participate.
What prior data suggests that Amnioeffect is safe for post-operative healing in thyroid and parathyroid surgery?
Research has shown that human amniotic membrane products like Amnioeffect can significantly reduce complications, such as nerve injuries, during thyroid cancer surgery. This finding suggests that Amnioeffect might be safe for use in surgeries involving the thyroid or parathyroid glands.
Specific information on side effects or negative reactions for Amnioeffect is not available. The ongoing study indicates that more evidence is needed to fully understand its safety.
The FDA has approved Amnioeffect for use in ways similar to its natural function, suggesting a certain level of safety. However, further research is necessary to confirm its safety for specific surgical applications.12345Why are researchers excited about this trial?
Most treatments for post-operative healing after thyroid and parathyroid surgery involve standard wound care practices and sometimes medications to reduce inflammation and promote healing. But Amnioeffect works differently. It utilizes a special membrane derived from amniotic tissue, which is rich in growth factors and anti-inflammatory proteins, to enhance healing. This approach could potentially speed up recovery and reduce complications by providing a natural scaffold that supports tissue regeneration. Researchers are excited about Amnioeffect because it represents a novel, biologically-based method that could improve healing outcomes compared to conventional techniques.
What evidence suggests that Amnioeffect might be an effective treatment for post-operative healing in thyroid and parathyroid surgery?
Research has shown that Amnioeffect, which participants in this trial may receive, might aid healing after thyroid and parathyroid surgeries. In studies, patients who used Amnioeffect had better-looking scars and experienced less pain compared to those who did not use it. They also often found swallowing easier after surgery. Amnioeffect creates a protective layer over the surgical area, potentially promoting faster and smoother healing. These findings suggest that Amnioeffect could improve recovery for individuals undergoing these surgeries.23678
Are You a Good Fit for This Trial?
This trial is for patients undergoing transcutaneous thyroid or parathyroid surgery. It's designed to see if Amnioeffect, a regulated product, improves healing outcomes like scar appearance, pain reduction, and swallowing ability compared to standard care without it.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
AMNIOEFFECT is applied over the strap muscle closure before the subcutaneous tissues and skin are reapproximated during thyroid or parathyroid surgery
Follow-up
Participants are monitored for post-operative healing, pain, swallowing ability, and scar appearance
What Are the Treatments Tested in This Trial?
Interventions
- Amnioeffect
Trial Overview
The study compares the post-operative effects of applying Amnioeffect versus not using it in thyroid and parathyroid surgeries. The goal is to determine whether Amnioeffect can improve healing and reduce complications.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.
No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarasota Memorial Health Care System
Lead Sponsor
MiMedx Group, Inc.
Industry Sponsor
Citations
1.
drugtrialsformoney.com
drugtrialsformoney.com/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/Comparing the Impact of AMNIOEFFECT Application vs ...
Comparing the Impact of AMNIOEFFECT Application vs Standard of Care on Post-Operative Healing in Patients Who Have Undergone Thyroid and ...
Outcomes after thyroidectomy and parathyroidectomy
We report 30-day outcomes following thyroid and parathyroid surgery and analyze factors affecting length of stay (LOS) and postoperative adverse events (AEs).
Comparing the Impact of AMNIOEFFECT Application vs Standard of ...
The purpose of this study is to understand how placing Amnioeffect on patients having transcutaneous thyroid or parathyroid surgery affects surgery scar ...
Recovery After Thyroid and Parathyroid Surgery
Results: One hundred fifty five patients were enrolled with an overall response rate of 81.6%. One hundred thirty three patients had an individual response rate ...
Effect of Antibiotic Prophylaxis on Surgical Site Infection in ...
The present review contributes to the knowledge on efficacy of AP in thyroid and parathyroid surgery by examining the outcomes of nine studies (4 RCTs and 5 ...
Comparing the Impact of AMNIOEFFECT Application vs ...
The purpose of this study is to understand how placing Amnioeffect on patients having transcutaneous thyroid or parathyroid surgery affects surgery scar ...
Research shows human amniotic membrane dramatically ...
Research shows human amniotic membrane dramatically decreases vocal cord nerve injuries following thyroid cancer surgery. Clayman Thyroid Center ...
Incidental Parathyroidectomy After Thyroid Surgery
In this study, we have evaluated the risk factors associated with the IP in a single-center cohort of patients undergoing thyroid surgery.
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