Clinical trial · Observational
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
NCT03479463CI-TRIAL-00048281terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment
Summary
Brief summary (as posted)
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
| Pharyngocutaneous Fistula | — | UNRESOLVED | — |
| Pharynx Cancer | Malignant Pharyngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dehydrated human amnion/chorion membrane | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Treatment with Dehydrated Human Amnion Chorion Allograft
- interventionNames
- Biological: Dehydrated human amnion/chorion membrane
- label
- Standard of Care
Primary outcomes (1)
- measure
- Incidence of Pharayngocutaneous Fistula Development (PCF)
- timeFrame
- 60 days
- description
- Incidence of PCF developement necessitating intervention within the 60 day time point.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.