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NCT02768467 · ClinicalTrials.gov registry record · NA
Buccal Mucosa Healing Trial With Tissue Matrix Placement
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT02768467: Completed NA study, sponsored by NYU Langone Health.
NCT02768467 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02768467, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects for which the wound can be closed without tension, the most recent study has shown improved pain outcomes in the immediate post-operative setting, although no difference is seen long term whether or not the wound was primarily closed. However, for larger defects, standard practice is to allow delayed healing by secondary intention. The use of Alloderm graft placement for donor site coverage was first described in Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to report the use of Alloderm failed to find a significant improvement in patient outcomes; however, very small defects were included in this study and the control group underwent primary closure, which has been shown to be inferior for large defects. Importantly, no increase in post-operative pain was noted, although there was some increased swelling reported. From experience, patients with moderate and large (\>2 cm width) defects following buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain, more rapid resumption of normal diet and mouth function with no associated increase in morbidity of the procedure. This study aims to determine whether this is a reliable improvement in technique. This study will clarify how the cheek heals after the buccal mucosa is removed during reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix or no stitches after the surgery. Subjects will be evaluated up to six months to determine if the outcomes of the tissue matrix graft are better for the subject.
Primary Outcome
Measured by the Visual Analog Scale
Interventions
- PROCEDURE Tissue Matrix Graft Placement
- PROCEDURE No Stitches
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2018-04-09 |
| Phase | NA |
What the finished NCT02768467 record still lists
NCT02768467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Tissue Matrix Graft Placement is the first listed.
NCT02768467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02768467 about?
NCT02768467 is a clinical study titled "Buccal Mucosa Healing Trial With Tissue Matrix Placement". Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects ...
What is the current status of trial NCT02768467?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2017-04-10. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT02768467?
The interventions under investigation include: Tissue Matrix Graft Placement (PROCEDURE), No Stitches (PROCEDURE).
Who is sponsoring clinical trial NCT02768467?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02768467's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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