Clinical Study Into the Cosmetic Results of Leukosan Adhesive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wound Healing Cosmetic Result

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Leukosan Adhesive

Leukosan Adhesive applied to one wound (left or right)

Group Type EXPERIMENTAL

Leukosan Adhesive

Intervention Type DEVICE

Leukosan adhesive applied to one wound

Transcutaneous suture

Intervention Type DEVICE

Transcutaneous suture applied to one wound

Transcutaneous suture

Transcutaneous suture applied to second wound (left or right)

Group Type ACTIVE_COMPARATOR

Leukosan Adhesive

Intervention Type DEVICE

Leukosan adhesive applied to one wound

Transcutaneous suture

Intervention Type DEVICE

Transcutaneous suture applied to one wound

Interventions

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Leukosan Adhesive

Leukosan adhesive applied to one wound

Intervention Type DEVICE

Transcutaneous suture

Transcutaneous suture applied to one wound

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No