Amnioeffect for Post-Operative Healing in Thyroid and Parathyroid Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sarasota Memorial Health Care System

Must not be taking: Immunosuppressants, Aminoglycosides

Disqualifiers: Pregnancy, Keloid scarring, Neck surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day (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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

I am having thyroid or parathyroid surgery through a skin cut.

I am willing and able to participate in the study.

I am 18 years old or older.

Exclusion Criteria

Patients with a known sensitivity to aminoglycoside antibiotics

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

Pregnant patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

AMNIOEFFECT is applied over the strap muscle closure before the subcutaneous tissues and skin are reapproximated during thyroid or parathyroid surgery

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for post-operative healing, pain, swallowing ability, and scar appearance

3 months

2 visits (in-person) at 1 month and 3 months post-procedure

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?

Group I: Amnioeffect Application Experimental Treatment 1 Intervention

AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated.

Group II: No Amnioeffect Application Active Control 1 Intervention

No AMNIOEFFECT placed over the strap muscle closure before the subcutaneous tissues and skin are reapproximated

Who Is Running the Clinical Trial?

Sarasota Memorial Health Care System

Lead Sponsor

Trials

5

Recruited

770+

MiMedx Group, Inc.

Industry Sponsor

Trials

36

Recruited

2,800+

Founded

2008

Headquarters

Marietta, USA

Known For

Placental Biologics

Top Products

EPIFIX, EPICORD, EPIEFFECT

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21638513/

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).

3. trialnavigator.com trialnavigator.com/trial/NCT07173621

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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36470201/

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 ...

5. mdpi.com mdpi.com/2079-6382/11/3/290

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07173621

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 ...

7. prnewswire.com prnewswire.com/news-releases/research-shows-human-amniotic-membrane-dramatically-decreases-vocal-cord-nerve-injuries-following-thyroid-cancer-surgery-301475017.html

Research shows human amniotic membrane dramatically ... Research shows human amniotic membrane dramatically decreases vocal cord nerve injuries following thyroid cancer surgery. Clayman Thyroid Center ...

8. mdpi.com mdpi.com/2227-9059/12/10/2372

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.