Buccal Mucosa Healing Trial With Tissue Matrix Placement

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

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 Overview

• Status: Completed
• Conditions: Tissue Grafts
• Intervention / Treatment: Procedure: Tissue Matrix Graft Placement; Procedure: No Stitches

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lee Zhao, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Allograft; Buccal Mucosa; Alloderm graft
• Other Study ID Numbers: 16-00669

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No