Clinical Study Into the Cosmetic Results of Leukosan Adhesive

Study Overview
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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.

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.

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

Conditions
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Wound Healing Cosmetic Result

Intervention / Treatment
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* Device: Leukosan Adhesive
* Device: Transcutaneous suture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leukosan Adhesive<br>Leukosan Adhesive applied to one wound (left or right) | Device: Leukosan Adhesive<br>* Leukosan adhesive applied to one wound<br>Device: Transcutaneous suture<br>* Transcutaneous suture applied to one wound<br>|
| Active Comparator: Transcutaneous suture<br>Transcutaneous suture applied to second wound (left or right) | Device: Leukosan Adhesive<br>* Leukosan adhesive applied to one wound<br>Device: Transcutaneous suture<br>* Transcutaneous suture applied to one wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction with cosmetic appearance/result of the wound | 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. | 3 months post operation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trocar incision, wound healing, cosmetic results