Tissue Grafts Clinical Trial
Official title:
A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement
| NCT number | NCT02768467 |
| Other study ID # | 16-00669 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 10, 2017 |
| Est. completion date | April 9, 2018 |
| Verified date | June 2019 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | April 9, 2018 |
| Est. primary completion date | April 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - >18 years of age - Male - Patients with clinically necessary buccal mucosal graft >2 cm - Patients who are able to present for pre-operative and post-operative evaluations - Patients who are able to comprehend and read English Exclusion Criteria: - History of oral cancer - Severe cognitive impairments - Unwilling or unable to follow procedures in protocol - Contraindicated to participate for any reason |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York University Langone Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Level | Measured by the Visual Analog Scale | Six months | |
| Secondary | Time to Normal Eating | This is measured by time. | Six Months | |
| Secondary | Presence of Swelling | This is measured by time | Six Months | |
| Secondary | Mouth mobility | This is measured by time | Six Months | |
| Secondary | Presence of Paresthesia | This is measured by time | Six Months |