Tissue GraftsNCT02768467
Buccal Mucosa Healing Trial With Tissue Matrix Placement
A study testing Tissue Matrix Graft Placement and No Stitches in people with Tissue Grafts, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Tissue Grafts
- What is being tested?
- Tissue Matrix Graft Placement and No Stitches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 9 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- History of oral cancer
- Severe cognitive impairments
- Unwilling or unable to follow procedures in protocol
- Contraindicated to participate for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- Tissue Grafts
- Being tested
- Tissue Matrix Graft Placement, No Stitches
- Keywords
- Alloderm graft, Allograft, Buccal Mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Matrix Graft PlacementProcedure or surgery
Subject will receive a covering for the wound post buccal mucosa removal.
No StitchesProcedure or surgery
Subject will not receive stitches post buccal mucosa removal.
| Study group | Role | What they receive |
|---|---|---|
| Tissue Matrix Graft Placement | Experimental | After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix Receives: 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. Receives: Procedure: No Stitches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Measured by the Visual Analog Scale
Measured: Six months
Secondary outcomes (4)
Time to Normal Eating
This is measured by time.
Measured: Six Months
Presence of Swelling
This is measured by time
Measured: Six Months
Mouth mobility
This is measured by time
Measured: Six Months
Presence of Paresthesia
This is measured by time
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start10 Apr 2017
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue GraftsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Zhao, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768467
- Sponsor's protocol ID
- 16-00669
- Status last verified
- Jun 2019
- First submitted
- 9 May 2016
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement
- ClinicalTrials.gov ID
- NCT02768467
- Acronym / sponsor ID
- 16-00669
- Conditions
- Tissue Grafts
- Keywords
- Alloderm graft, Allograft, Buccal Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Matrix Graft Placement | Experimental | Procedure: Tissue Matrix Graft PlacementAfter the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix |
| Without stitches | Active comparator | Procedure: No StitchesAfter the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (4 listed)
- History of oral cancer
- Severe cognitive impairments
- Unwilling or unable to follow procedures in protocol
- Contraindicated to participate for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Matrix Graft PlacementSubject will receive a covering for the wound post buccal mucosa removal. | Procedure or surgery | Tissue Matrix Graft Placement |
| No StitchesSubject will not receive stitches post buccal mucosa removal. | Procedure or surgery | Without stitches |
Primary outcome
Pain Level
Time frame: Six months
Measured by the Visual Analog Scale
4 secondary outcomes
Time to Normal Eating
Time frame: Six Months
Presence of Swelling
Time frame: Six Months
Mouth mobility
Time frame: Six Months
Presence of Paresthesia
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Zhao, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Matrix Graft Placement and No Stitches in people with Tissue Grafts, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.