Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

Larynx Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03479463
• Other study ID #: AFSUR003
• Status: Terminated
• Start date: March 19, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: November 2020
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fistula
• Laryngeal Neoplasms
• Larynx Cancer
• Pharyngeal Neoplasms
• Pharyngocutaneous Fistula
• Pharynx Cancer

Intervention

Biological:
• Dehydrated human amnion/chorion membrane
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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