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临床试验/NCT03685565
NCT03685565已完成不适用

Cosmetic Outcomes of Simple Facial Lacerations Repaired With Dermabond Compared With Dermabond With Underlying Steristrips: A Randomized Controlled Trial

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年9月15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
120
试验地点
2
主要终点
Cosmesis

研究概览

简要总结

The purpose of the study is to compare cosmetic outcomes of simple facial lacerations in children repaired with Dermabond (skin glue) compared with Dermabond (skin glue) with underlying steristrips (skin adhesive strips).

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age ≤17 years old
  • Presents with simple, linear facial laceration requiring repair
  • English or Spanish speaking parents or guardians

排除标准

  • Laceration to lips, nose, ear, eyelids, eyebrows
  • Laceration requiring multi-layer closure
  • Laceration requiring sub-specialty care
  • Laceration that has previously been repaired
  • Animal/human bites
  • Lacerations >5cm in length
  • Allergy to adhesive

结局指标

主要结局

Cosmesis

时间窗: 2 months after repair

cosmetic scar outcome; photo will be taken of scar at 2 months and graded using a visual analog scale (VAS) by blinded reviewers. The VAS is a 0-100mm standardized scale where 0mm represents the "worst scar" and 100mm represents the "best scar" and reviewers will place a marking along the line of where they feel the scar belongs.

次要结局

  • Ease of repair of laceration(Day 0 (physician will complete just after the repair))
  • Time to repair laceration(Day 0 (physician will complete just after the repair))
  • Type of analgesia & sedation required(Day 0 (physician will complete just after the repair))
  • Wound dehiscence(1 week)
  • Wound infection(1 week)

研究者

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

Erin D Munns

Fellow Physician

University of Texas at Austin

研究点 (2)

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