Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair With Orbicularis Reconstruction, in Secondary Unilateral Cleft Lip Revision (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS).
研究概览
简要总结
Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair.
- The first group will receive upper lip fat injections into the philtral column (and other areas of volume insufficiency if needed) after manual fat liposuction from the abdomen.
- The second group will receive surgical lip revision with reconstruction of the orbicularis oris muscle using inverted horizontal mattress sutures for enhancement of the philtral ridge.
详细描述
Interventions:
A. Intervention group: Fat injection
Harvesting fat from the donner site:
- Surgical repair is to be done under general anesthesia.
- IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
- Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).
- The lipoaspirate is to be harvested from the donor site using manual liposuction through a small incision (less than 0.5 cm). Fat is aspirated using a blunt tipped catheter on a 10-mL syringe.
- The fat is emulsified.
Injecting fat into the lip:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Each patient will be given a code by the main researcher and the raters will be blind to which group this case belongs. Patients, raters and statistician will be blinded
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with repaired unilateral cleft lip deformity.
- •Mild to moderate grooving and/or scarring of the philtral column.
- •Patients who require a secondary cleft lip repair.
- •Age of the patient between 4 & 16 years
- •All patients are free from any systemic disease that may affect normal tissue healing.
排除标准
- •Patients older than 16 years old or whose caregivers declined a revisionary operation.
- •Patients with any systemic disease that may affect normal healing.
- •Patients with any other craniofacial malformation.
- •Syndromic cleft patients.
结局指标
主要结局
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS).
时间窗: preoperative, immediate postoperative, after one year.
Change in philtral column height as assessed using photographs and scores of a visual analogue scale (scale described below). 1. Same height as the normal side 2. Less prominent than the normal side 3. Flat philtral column 4. Slight groove 5. Prominent groove ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column projection in mm using a special device clinically.
时间窗: preoperative, immediate postoperative, after one year.
Change in philtral column projection as assessed clinically using a special device to obtain quantitative measurements of philtral column projection in mm.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in height and projection of philtral column in mm using lip ultrasonography.
时间窗: preoperative, immediate postoperative, after one year.
Change in height and projection of philtral column as assessed using lip ultrasonography to obtain quantitative measurements of philtral column height and projection in mm.
次要结局
- Efficacy of fat injection (or lip revision surgery) in scar tissue modulation measured by assessing change in the appearance of the scar using photographs and scores of a VAS preoperatively, immediately postoperative and after one year.(preoperative, immediate postoperative, after one year)
- Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey.(After one year)
研究者
Shereen Ishak Faris
Assistant Researcher
Cairo University