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

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
United States
New York
New York University Langone Medical Center
New York
Time Frame
Start Date: 2017-04-10
Completion Date: 2018-04-09
Participants
Target number of participants: 50
Treatments
Experimental: Tissue Matrix Graft Placement
After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix
Active_comparator: Without stitches
After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.
Authors
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov