Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

Stopped early

Conditions studied: Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula

In brief

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

Key facts

Study ID

NCT03479463

Run by

MiMedx Group, Inc.

People needed

8

Starts

2018-03-19

Expected to finish

2019-03-30

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects currently enrolled in or planning to enroll in another clinical trial
• Subjects with a known history of poor compliance with medical treatments
• Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
• Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
• Subject has undergone previous pharyngeal reconstructive surgery
• 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)

Where it is running

• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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