Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

November 12, 2020 updated by: MiMedx Group, Inc.

A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery

This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029-6574
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a single-center, matched case registry. The medical records of approximately 40 patients meeting all documentation and eligibility requirements will comprise the retrospective cohort. A total of 40 subjects will be enrolled prospectively at Mount Sinai Hospital. It is expected that the majority of the subjects will be recruited through the investigators' standard admission practices. All subjects selected for the study will not be excluded because of race or ethnicity and all efforts will be made to adequately represent the patient population in the area in which they are chosen.

Description

Inclusion Criteria:

  1. Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
  2. Subject is age 18 or older
  3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

  1. Subjects currently enrolled in or planning to enroll in another clinical trial
  2. Subjects with a known history of poor compliance with medical treatments
  3. Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
  4. Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
  5. Subject has undergone previous pharyngeal reconstructive surgery
  6. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment with Dehydrated Human Amnion Chorion Allograft
Biological: Dehydrated human amnion/chorion membrane
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pharayngocutaneous Fistula Development (PCF)
Time Frame: 60 days
Incidence of PCF developement necessitating intervention within the 60 day time point.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiMedx Group, Inc.

Investigators

  • Principal Investigator: Brett Miles, MD, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 24, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSUR003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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