Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

NCT03479463 | Terminated DMC

• 1 other identifier: AFSUR003
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Larynx Cancer; Pharynx Cancer; Pharyngocutaneous Fistula

Outcome Measures

Primary Outcomes (1)

• Incidence of Pharayngocutaneous Fistula Development (PCF)

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

  60 days

Study Arms (2)

Treatment with Dehydrated Human Amnion Chorion Allograft

Biological: Dehydrated human amnion/chorion membrane

Standard of Care

Interventions

Dehydrated human amnion/chorion membrane BIOLOGICAL

Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft

Treatment with Dehydrated Human Amnion Chorion Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-center, matched case registry. The medical records of approximately 40 patients meeting all documentation and eligibility requirements will comprise the retrospective cohort. A total of 40 subjects will be enrolled prospectively at Mount Sinai Hospital. It is expected that the majority of the subjects will be recruited through the investigators' standard admission practices. All subjects selected for the study will not be excluded because of race or ethnicity and all efforts will be made to adequately represent the patient population in the area in which they are chosen.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029-6574, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms; Pharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Brett Miles, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 150 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 19, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)