Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Patient's satisfaction with cosmetic appearance/result of the wound
研究概览
简要总结
This clinical study aims to assess whether the benefits of using Leukosan Adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures.
In particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with Leuksan Adhesive.
An open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of March 2013 and April 2013.
详细描述
The medical devices compared were EU (European Union) approved market-ready products with relevant designation according to the legal requirements for medical devices and according to Council guideline 93/42/EWG dated 14th July.
Leukosan Adhesive is a sterile, ultra high viscose adhesive for external skin closure. Due to the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film firmly holding the edges of the wound together and protecting the wound itself.
Premilene DSMP 24, 3/8 needle, thread 3/0 denier was used a a comparison. This suture material was the standard suture material used in the study centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 60
- •Undergone laparoscopic operation with 2 mirror image trocar incisions
- •Willing to attend examination at clinic at 7-12 days and 10-14 weeks
- •Signed agreement by participant
排除标准
- •Length of laparoscopic operation more than 2 hours
- •Hospitalisation due to complications
- •Circumstances leading to difference in trocar incisions
- •Existing scar less than 3 cm from the operation point
- •Diabetic condition melitis HbA1c>9mg/d
- •Known allergy to tissue adhesive
- •Participation in another study within 30 days
结局指标
主要结局
Patient's satisfaction with cosmetic appearance/result of the wound
时间窗: 3 months post operation
The primary outcome was the satisfaction of the patients with the cosmetic result of the wound healing after 3 months. This was measured by a visual analogue scale. In order to validate this result, an additional known wound assessment instrument, an ordinal scaled index, was implemented and the assessment of independent assessors was called on.
次要结局
- The incidence of complication(7-12 days post-operation)
- Intensity of pain(7-12 days post-operation)
- Investigator's assessment of cosmetic outcome(At 3 months post-operation)
研究者
Dr. Stephanie Krause
Scientific Affairs, Wound Care
BSN Medical GmbH