NCT01264588已完成不适用
A Randomized, Single Blind, Comparative, Controlled Study On The Effects Of Topical Calcium Glycerophosphate On Surgical Wound Healing And Residual Scarring In Bilateral Total Knee Arthroplasty Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement of surgical wound appearance
研究概览
简要总结
The purpose of this study is to determine whether topical application of calcium glycerophosphate will result in superior wound appearance and scar minimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent must be obtained
- •45-75 years of age
- •Scheduled for bilateral knee replacement surgery
排除标准
- •Employee or immediate family of either AkPharma or employee or immediate family of investigator or site personnel
- •Pregnant or breast feeding Known allergy or hypersensitivity to calcium or phosphorus supplements
- •Diagnosed with type I or type II diabetes mellitus
结局指标
主要结局
Improvement of surgical wound appearance
时间窗: Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365
Digital photographs as objective measurements are taken at each time point, and evaluated by an Expert Grader, blinded as to treatment vs. control, for any differences in the time required for wound closure and/ or scar minimization between treated and untreated groups.
次要结局
- Reduction of visible erythema/ inflammation(Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365)
- Scar minimization or prevention(Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365)
- Incision/ scar pain and sensitivity(Post-Op Day: 3 (baseline), 7, 14, 42, 70, 98, 180, 365)
- Range of motion(Post-Op Day: 3 (baseline), 7, 42, 180, 365)
研究者
研究点 (2)
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