Buccal Mucosa Healing Trial With Tissue Matrix Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2018-04-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites

NCT04234750

Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites

UNKNOWN PHASE1

Stem Cells In Wound Healing With Collagen Matrix as a Carrier

NCT02314416

Wounds

WITHDRAWN PHASE4

The Molecular Anatomy of Oral Wound Healing

NCT01078467

Wounds and Injuries Wound Healing Ulcer

COMPLETED

Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

NCT01348581

Pressure Ulcers Venous Ulcers Diabetic Ulcers +2 more

COMPLETED NA

Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects

NCT02672280

Wounds Diabetic Foot Ulcers Burns

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tissue Grafts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tissue Matrix Graft Placement

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

Group Type EXPERIMENTAL

Tissue Matrix Graft Placement

Intervention Type PROCEDURE

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

Without stitches

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

Group Type ACTIVE_COMPARATOR

No Stitches

Intervention Type PROCEDURE

Subject will not receive stitches post buccal mucosa removal.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tissue Matrix Graft Placement

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

Intervention Type PROCEDURE

No Stitches

Subject will not receive stitches post buccal mucosa removal.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No