Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

Terminated

• Conditions: Pharynx Cancer; Pharyngocutaneous Fistula; Larynx Cancer
• Interventions: Biological: Dehydrated human amnion/chorion membrane

• Registration Number: NCT03479463
• Lead Sponsor: MiMedx Group, Inc.

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 Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-24
• Study First Posted: 2018-03-27
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with Dehydrated Human Amnion Chorion Allograft	Dehydrated human amnion/chorion membrane	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States