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

MiMedx Group, Inc.1 site in 1 country8 target enrollmentMarch 19, 2018

ConditionsLarynx Cancer Pharynx Cancer Pharyngocutaneous Fistula

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Larynx Cancer
Sponsor: MiMedx Group, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Incidence of Pharayngocutaneous Fistula Development (PCF)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 19, 2018

End Date

March 30, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MiMedx Group, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)