Buccal Mucosa Healing Trial With Tissue Matrix Placement

Study Overview
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Brief Summary
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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.

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

Conditions
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Tissue Grafts

Intervention / Treatment
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* Procedure: Tissue Matrix Graft Placement
* Procedure: No Stitches


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue Matrix Graft Placement<br>After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix | Procedure: Tissue Matrix Graft Placement<br>* Subject will receive a covering for the wound post buccal mucosa removal.<br>|
| Active Comparator: Without stitches<br>After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal. | Procedure: No Stitches<br>* Subject will not receive stitches post buccal mucosa removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | Measured by the Visual Analog Scale | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Normal Eating | This is measured by time. | Six Months | 
| Presence of Swelling | This is measured by time | Six Months | 
| Mouth mobility | This is measured by time | Six Months | 
| Presence of Paresthesia | This is measured by time | Six Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alloderm graft, Allograft, Buccal Mucosa