Clinical trial NCT02768467: Buccal Mucosa Healing Trial With Tissue Matrix Placement
Official title: A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Grafts
Keywords: Alloderm graft
Allograft
Buccal Mucosa
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Level
timeFrame: Six months
Secondary outcomes:
measure: Time to Normal Eating
timeFrame: Six Months
measure: Presence of Swelling
timeFrame: Six Months
measure: Mouth mobility
timeFrame: Six Months
measure: Presence of Paresthesia
timeFrame: Six Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lee Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: