A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare cosmetic outcomes at follow up
研究概览
简要总结
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 18 or older on day of enrollment
- •Scheduled for surgical procedure by a delegated study surgeon
- •Fresh surgical wound with evenly distributed tension over length of incision
- •Willing and able to sign informed consent
- •Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit
排除标准
- •Known sensitivity to cyanoacrylates, formaldehyde or acetone products
- •Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
- •Wounds less than 15mm in length
- •Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level >2.5 prior to surgery
- •Wounds in which deep closure could not be achieved
- •Surgical procedures involving mucus membranes or eyes
- •Mental incapacity, dementia, or inability to give informed consent
- •Pregnant or nursing
- •Disease related or pharmacologically immuno-compromised
研究组 & 干预措施
LiquiBand Flex
LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures.
干预措施: LiquiBand Flex (Device)
Dermabond Advanced
Dermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
干预措施: Dermabond Advanced (Device)
Sutures (Prolene)
Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
干预措施: Sutures (Prolene) (Device)
结局指标
主要结局
To compare cosmetic outcomes at follow up
时间窗: 3 months post treatment
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale
次要结局
未报告次要终点