TerminatedNot Applicable

Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

Stopped: Slow enrollment

United States8 participantsStarted 2018-03-19

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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)

Incidence of Pharayngocutaneous Fistula Development (PCF)

Timeframe: 60 days

NCT IDNCT03479463

SponsorMiMedx Group, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-03-30