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Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03479463
Recruitment Status : Terminated (Slow enrollment)
First Posted : March 27, 2018
Last Update Posted : November 13, 2020
Information provided by (Responsible Party):
MiMedx Group, Inc.

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

Condition or disease Intervention/treatment
Larynx Cancer Pharynx Cancer Pharyngocutaneous Fistula Biological: Dehydrated human amnion/chorion membrane

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 150 Days
Official Title: A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

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

Primary Outcome Measures :
  1. Incidence of Pharayngocutaneous Fistula Development (PCF) [ Time Frame: 60 days ]
    Incidence of PCF developement necessitating intervention within the 60 day time point.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03479463

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United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029-6574
Sponsors and Collaborators
MiMedx Group, Inc.
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Principal Investigator: Brett Miles, MD MOUNT SINAI HOSPITAL
Additional Information:

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Responsible Party: MiMedx Group, Inc. Identifier: NCT03479463    
Other Study ID Numbers: AFSUR003
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Pharyngeal Neoplasms
Pathological Conditions, Anatomical
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases