Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Ultrasonography
研究概览
简要总结
The study is being conducted to objectively assess tissue changes following the use of P4HB in rhytidectomy to understand how the utilization of the surgical mesh may affect tissue mechanical strength and elasticity, wound healing, and scar formation dynamics.
详细描述
This is a prospective study designed to follow six (6) qualified and consenting adults, 18-80 years of age scheduled for an elective rhytidectomy with the Principal Investigator (PI). Subjects will be evaluated at baseline, month 1, month 6 and month 12. The effects of the study device will be analyzed at all follow up visits through clinical/3D photography, non-invasive skin assessments and subject/physician questionnaires. The PI will be collecting tissue samples during their surgical procedure, month 6 and month 12 visits. Histopathology will be completed on the collected sample to assess changes of the tissue after the subjects rhytidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria
- •Inclusion Criteria
- •Healthy adults 18-80 years of age
- •Planned/scheduled rhytidectomy at UT Southwestern with the study doctor
- •Willing to return for follow up visits and undergo study evaluations
排除标准
- •Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc)
- •Individuals who have significant scarring on the test area
- •Individuals with a disorder to negatively affect wound healing
结局指标
主要结局
Ultrasonography
时间窗: Baseline, Month 3 and Month 6 and Month 12
Ultrasonography will be used to evaluate the skin thickness and density for research purposes.
Bio-mechanical Tissue Characterization
时间窗: Baseline, Month 3 and Month 6 and Month 12
BTC will be used to measure skins laxity, viscoelasticity deformation, stiffness, energy absorption, elasticity, and deformation values for research purposes. Change from baseline will be calculated to assess change
次要结局
- Instron Biomedical Testing(Baseline, Month 6 and Month 12)
- Face-Q: Satisfaction with Facial Appearance(Baseline, Month 6 and Month 12)
- Face-Q: Satisfaction with Outcome(Baseline, Month 6 and Month 12)
- Histological Assessment(Baseline, Month 6 and Month 12)
研究者
Jeffrey M. Kenkel
Chairman and Professor
University of Texas Southwestern Medical Center