NCT02768467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

April 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

May 9, 2016

Last Update Submit

June 3, 2019

Conditions

Tissue Grafts

Keywords

Alloderm graftAllograftBuccal Mucosa

Outcome Measures

Primary Outcomes (1)

  • Pain Level

    Measured by the Visual Analog Scale

    Six months

Secondary Outcomes (4)

  • Time to Normal Eating

    Six Months

  • Presence of Swelling

    Six Months

  • Mouth mobility

    Six Months

  • Presence of Paresthesia

    Six Months

Study Arms (2)

Tissue Matrix Graft Placement

EXPERIMENTAL

After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix

Procedure: Tissue Matrix Graft Placement

Without stitches

ACTIVE COMPARATOR

After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.

Procedure: No Stitches

Interventions

Tissue Matrix Graft PlacementPROCEDURE

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

Tissue Matrix Graft Placement
No StitchesPROCEDURE

Subject will not receive stitches post buccal mucosa removal.

Without stitches

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • History of oral cancer
  • Severe cognitive impairments
  • Unwilling or unable to follow procedures in protocol
  • Contraindicated to participate for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Study Officials

  • Lee Zhao, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

April 10, 2017

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

US(1)