DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
研究概览
简要总结
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective Group:
- •Unilateral cleft lip with or without cleft palate
- •Patients of a single surgeon (Matthew Greives, MD)
- •Patients with complete photographs:
- •After birth, first visit
- •At cleft lip repair (3-4 months)
- •Post-operative cleft repair (about 1 year of age)
- •Prospective Group:
- •Patients with incomplete unilateral cleft lip with or without cleft palate
- •Patients of any surgeon
排除标准
- •Retrospective Group:
- •Bilateral cleft lip or complete unilateral cleft lip
- •Patients operated on by other primary surgeons
- •Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
- •Prospective Group:
- •Patients with bilateral cleft lip or complete unilateral cleft lip
- •Patients whose parents refuse to consent to inclusion
- •Patients with tape allergies to the adhesive of the DynaCleft®
- •Patients with syndromic craniofacial conditions or Tessier type facial clefts
结局指标
主要结局
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
时间窗: initial time of examination with study team, time of surgery (3 months post intervention)
Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
时间窗: initial time of examination with study team, time of surgery (3 months post intervention)
Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.
Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs
时间窗: initial time of examination with study team, time of surgery (3 months post intervention)
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs
时间窗: initial time of examination with study team, time of surgery (3 months post intervention)
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
次要结局
- Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire(initial time of examination with study team, time of surgery (3 months post intervention))
研究者
Brett Thomas Chiquet
Associate Professor
The University of Texas Health Science Center, Houston