Clinical Study Into the Cosmetic Results of Leukosan Adhesive

Dr. Stephanie Krause

Status: Completed

Conditions: Wound Healing Cosmetic Result

Treatments: Device: Transcutaneous suture; Device: Leukosan Adhesive

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179723

PV4003 (Other Identifier)

BSNMedicalC09962

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 77 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

77 participants in 2 patient groups

Leukosan Adhesive

Experimental group

Description:

Leukosan Adhesive applied to one wound (left or right)

Treatment:

Device: Transcutaneous suture

Device: Leukosan Adhesive

Transcutaneous suture

Active Comparator group

Description:

Transcutaneous suture applied to second wound (left or right)

Treatment:

Device: Transcutaneous suture

Device: Leukosan Adhesive