Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03479463

Enrollment

Registered

2018-03-27

Start date

2018-03-19

Completion date

2019-03-30

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Larynx Cancer, Pharyngocutaneous Fistula, Pharynx Cancer

Brief summary

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

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.

Interventions

BIOLOGICALDehydrated human amnion/chorion membrane

Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026