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Completed Not applicable Interventional

Buccal Mucosa Healing Trial With Tissue Matrix Placement

ClinicalTrials.gov ID: NCT02768467

Public ClinicalTrials.gov record NCT02768467. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02768467
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
NYU Langone Health
Other
Enrollment
50 participants

Conditions and interventions

Conditions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 9, 2017
Primary completion
Apr 8, 2018
Completion
Apr 8, 2018
Last update posted
Jun 4, 2019

2017 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
New York University Langone Medical Center New York New York 10016

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02768467, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 4, 2019 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02768467 live on ClinicalTrials.gov.

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