- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02768467
Buccal Mucosa Healing Trial With Tissue Matrix Placement
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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New York
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New York, New York, 미국, 10016
- New York University Langone Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tissue Matrix Graft Placement
After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix
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Subject will receive a covering for the wound post buccal mucosa removal.
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활성 비교기: Without stitches
After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.
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Subject will not receive stitches post buccal mucosa removal.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Level
기간: Six months
|
Measured by the Visual Analog Scale
|
Six months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Normal Eating
기간: Six Months
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This is measured by time.
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Six Months
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Presence of Swelling
기간: Six Months
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This is measured by time
|
Six Months
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Mouth mobility
기간: Six Months
|
This is measured by time
|
Six Months
|
|
Presence of Paresthesia
기간: Six Months
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This is measured by time
|
Six Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lee Zhao, MD, NYU Langone Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 16-00669
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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