Tissue Grafts
Conditions
Keywords
Alloderm graft, Allograft, Buccal Mucosa
Brief 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.
Interventions
PROCEDURETissue Matrix Graft Placement
Subject will receive a covering for the wound post buccal mucosa removal.
PROCEDURENo Stitches
Subject will not receive stitches post buccal mucosa removal.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | Six months | Measured by the Visual Analog Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Normal Eating | Six Months | This is measured by time. |
| Presence of Swelling | Six Months | This is measured by time |
| Mouth mobility | Six Months | This is measured by time |
| Presence of Paresthesia | Six Months | This is measured by time |
Countries
United States
Outcome results
None listed