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临床试验/NCT03748459
NCT03748459已完成不适用

Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure

Medical University of South Carolina0 个研究点目标入组 60 人开始时间: 2017年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Patient Scar Assessment

研究概览

简要总结

Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent skin sutures. These sutures create less inflammation and are thought to lead to improved final scar outcomes. However, permanent sutures require removal which creates pain and inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require removal. The difference in final scar outcome based on suture material used has not been well studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured with traditional permanent suture compared to fast absorbing suture. If scar outcomes are similar between these groups as judged by the patients and blinded observers, rhinoplasty surgeons may be able to preferentially utilize absorbable sutures for incision closure and avoid the pain and inconvenience for the patient during suture removal

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient Scar Assessment

时间窗: 12 months after surgery

Patient scar assessment will be done with a patient completed questionnaire. The questionnaire is a validated scar assessment instrument for self rating of surgical scars by patients for a minimum rating of 28 (best scar) to 112 (worst scar)

Clinician Scar Assessment

时间窗: 12 months after surgery

Clinician scar assessment will be done using photographs of the scar 12 months after surgery. Clinicians will use a validated clinician scar grading tool for evaluation of surgical scars with a range of 0 (worst scar) to 5 (best scar)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Oyer

Assistant Professor

Medical University of South Carolina

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