Clinical Study Into the Cosmetic Results of Leukosan Adhesive

Not Applicable

Completed

• Conditions: Wound Healing Cosmetic Result
• Interventions: Device: Leukosan Adhesive; Device: Transcutaneous suture

• Registration Number: NCT02179723
• Lead Sponsor: Dr. Stephanie Krause

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-04
• Study Completion: 2013-07
• Status Verified: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Last Update Submitted: 2014-06-30
• Study First Posted: 2014-07-02
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leukosan Adhesive	Leukosan Adhesive	Leukosan Adhesive applied to one wound (left or right)
Leukosan Adhesive	Transcutaneous suture	Leukosan Adhesive applied to one wound (left or right)
Transcutaneous suture	Leukosan Adhesive	Transcutaneous suture applied to second wound (left or right)
Transcutaneous suture	Transcutaneous suture	Transcutaneous suture applied to second wound (left or right)

Primary Outcome Measures

Name	Time	Method
Patient's satisfaction with cosmetic appearance/result of the wound	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of complication	7-12 days post-operation	7-12 days post-operation patients were examined for complications in treatment such as wound dehiscence, maceration, redness, overheating and pain
Intensity of pain	7-12 days post-operation	7-12 days post-operation patients were examined for intensity of pain
Investigator's assessment of cosmetic outcome	At 3 months post-operation	The Investigator examined patients to assess the cosmetic outcome.

Trial Locations

Locations (1)

Tagesklinik Altonaer Strasse; 🇩🇪 Hamburg, Germany