Slow enrollment

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

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

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)

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.