- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07647458
Quantifying Adhesive Residue on Skin Following Removal of Maxillofacial Prosthetic Adhesives: An In Vivo Study (ARMS)
A Comparative Assessment of Adhesive Residue on the Skin Following the Removal of Extraoral Silicone Prosthesis: An In Vivo Study
연구 개요
상태
정황
상세 설명
This pilot interventional in vivo study is designed to quantitatively evaluate and compare the amount of adhesive residue left on the skin following removal of extraoral maxillofacial prosthetic adhesives. Adhesive-retained facial prostheses are widely used in maxillofacial rehabilitation; however, residual adhesive remaining on the skin after prosthesis removal may contribute to patient discomfort, skin irritation, and difficulty in daily prosthesis maintenance. Despite its clinical importance, adhesive residue has not been quantitatively evaluated in vivo.
Five commercially available maxillofacial prosthetic adhesives, including silicone-based and water-based formulations, will be evaluated using standardized silicone elastomer strips. Five healthy volunteers between 18 and 30 years of age will be recruited. Thirty test sites will be prepared on the volar surfaces of the forearms, with six sites allocated to each adhesive group through block randomization. Participants with skin diseases, adhesive allergies, systemic conditions affecting skin integrity, pregnancy, lactation, or recent skin injuries will be excluded.
Standardized silicone strips measuring 60 × 20 × 3 mm will be fabricated and coated with a uniform quantity of adhesive. After a drying period of 3 minutes, the strips will be applied to designated skin sites and maintained for 8 hours during normal daily activities. Following removal, the strips will be reweighed using a high-precision analytical balance. Adhesive residue remaining on the skin will be quantified using gravimetric analysis by calculating the percentage difference between initial and final strip weights.
The primary outcome measure is the percentage of adhesive residue remaining on the skin after removal of the prosthetic adhesive. Secondary objectives include assessment of adhesive failure modes and comparison of residue patterns between silicone-based and water-based adhesive systems.
To minimize bias, participant allocation sites will be randomized and both participants and investigators involved in application and evaluation procedures will remain blinded to adhesive identity. Statistical analysis will be performed using one-way analysis of variance followed by post hoc multiple comparison testing. The findings of this study may help clinicians select adhesive systems that optimize prosthesis retention while minimizing skin trauma and patient burden during long-term maxillofacial rehabilitation.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kerala
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Kochi, Kerala, 인도, 682041
- Amrita School of Dentistry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Healthy volunteers aged 18-30 years
- Willingness to participate and provide written informed consent
- No history of skin disease
- No known adhesive allergy
Exclusion Criteria:
- Age below 18 years or above 30 years
- Current use of medications affecting skin integrity or immune function
- Recent skin trauma, surgery, or active skin lesions
- Existing systemic disease affecting skin health
- Pre-existing dermatological conditions
- Pregnancy or lactation
- Known allergy or hypersensitivity to adhesives or silicone materials
- Participation in another clinical trial during the study period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Adhesive Evaluation Group
All participants receive applications of five commercially available maxillofacial prosthetic adhesives at randomized skin sites on the volar forearms using standardized silicone strips.
Adhesive residue remaining on the skin after 8 hours of wear is quantitatively evaluated using gravimetric analysis.
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Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (ADM Tronics Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of adhesive residue remaining on skin after 8 hours
기간: 8 hours
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Quantitative assessment of adhesive residue remaining on the skin after removal of standardized silicone strips coated with maxillofacial prosthetic adhesives using gravimetric analysis.
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8 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adhesive Failure Mode Classification
기간: 8 hours
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Assessment of adhesive failure mode following removal of the silicone strip. Failure mode will be classified as:
Classification will be performed by visual inspection of the skin and silicone strip after removal. |
8 hours
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Time Required for Complete Adhesive Removal (Cleanability Assessment)
기간: 8 hours
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Cleanability will be assessed by measuring the time (in seconds) required to completely remove residual adhesive from the skin using a standardized cleaning procedure.
Lower cleaning times indicate greater cleanability.
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8 hours
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Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives
기간: 8 hours
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Comparison of percentage adhesive residue remaining on skin between silicone-based and water-based adhesive formulations, measured using gravimetric analysis.
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8 hours
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. Orthop Nurs. 2013 Sep-Oct;32(5):267-81. doi: 10.1097/NOR.0b013e3182a39caf.
- Rajasekaran R, Chander NG, Reddy JR, Balasubramanium M. Estimation of differences and reapplication effect of peel bond strength between silicone-based and water-based adhesives. J Prosthet Dent. 2024 Jun;131(6):1276-1279. doi: 10.1016/j.prosdent.2022.05.024. Epub 2022 Jun 25.
- Kiat-amnuay S, Gettleman L, Khan Z, Goldsmith LJ. Effect of adhesive retention on maxillofacial prostheses. Part I: skin dressings and solvent removers. J Prosthet Dent. 2000 Sep;84(3):335-40. doi: 10.1067/mpr.2000.109507.
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 (실제)
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
- ECASM-AIMS-2024-085
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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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