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Completed

NCT Number: NCT02768467

Buccal Mucosa Healing Trial 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue Matrix Graft Placement

Procedure

Subject will receive a covering for the wound post buccal mucosa removal.

No Stitches

Procedure

Subject will not receive stitches post buccal mucosa removal.

Primary outcomes

  1. Pain Level

    Time frame: Six months

    Measured by the Visual Analog Scale

Secondary outcomes

  1. Time to Normal Eating

    Time frame: Six Months

    This is measured by time.

  2. Presence of Swelling

    Time frame: Six Months

    This is measured by time

  3. Mouth mobility

    Time frame: Six Months

    This is measured by time

  4. Presence of Paresthesia

    Time frame: Six Months

    This is measured by time

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2016
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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