Completed

NCT Number: NCT02179723

Clinical Study Into the Cosmetic Results of Leukosan Adhesive

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wound Healing Cosmetic Result

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tagesklinik Altonaer Strasse

Hamburg, 20357, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leukosan Adhesive

Device

Leukosan adhesive applied to one wound

Transcutaneous suture

Device

Transcutaneous suture applied to one wound

Primary outcomes

Patient's satisfaction with cosmetic appearance/result of the wound

Time frame: 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 outcomes

The incidence of complication

Time frame: 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

Time frame: 7-12 days post-operation

7-12 days post-operation patients were examined for intensity of pain
Investigator's assessment of cosmetic outcome

Time frame: At 3 months post-operation

The Investigator examined patients to assess the cosmetic outcome.

Sponsors and collaborators

Lead sponsor

Dr. Stephanie Krause

Industry

Registry information

Official study title

Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 2, 2014
Registry last updated: Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.