Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

MiMedx

Status: Terminated

Conditions: Pharyngocutaneous Fistula; Pharynx Cancer; Larynx Cancer

Treatments: Biological: Dehydrated human amnion/chorion membrane

Study type: Observational

Funder types: Industry

Identifiers

NCT03479463

AFSUR003

Details and patient eligibility

About

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

Full description

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

8 participants in 2 patient groups

Treatment with Dehydrated Human Amnion Chorion Allograft

Treatment:

Biological: Dehydrated human amnion/chorion membrane

Standard of Care