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Clinical Trials/NCT03479463
NCT03479463TerminatedNot Applicable

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 enrollmentStarted: March 19, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
8
Locations
1
Primary Endpoint
Incidence of Pharayngocutaneous Fistula Development (PCF)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Incidence of Pharayngocutaneous Fistula Development (PCF)

Time Frame: 60 days

Incidence of PCF developement necessitating intervention within the 60 day time point.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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