Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Patient's satisfaction with cosmetic appearance/result of the wound
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Leukosan Adhesive
Leukosan Adhesive applied to one wound (left or right)
Intervention: Leukosan Adhesive (Device)
Leukosan Adhesive
Leukosan Adhesive applied to one wound (left or right)
Intervention: Transcutaneous suture (Device)
Transcutaneous suture
Transcutaneous suture applied to second wound (left or right)
Intervention: Leukosan Adhesive (Device)
Transcutaneous suture
Transcutaneous suture applied to second wound (left or right)
Intervention: Transcutaneous suture (Device)
Outcomes
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(7-12 days post-operation)
- Intensity of pain(7-12 days post-operation)
- Investigator's assessment of cosmetic outcome(At 3 months post-operation)
Investigators
Dr. Stephanie Krause
Scientific Affairs, Wound Care
BSN Medical GmbH