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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
Leukosan adhesive applied to one wound
Transcutaneous suture applied to one wound
Tagesklinik Altonaer Strasse
Hamburg, Germany
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.
Time frame: 3 months post operation
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
Time frame: 7-12 days post-operation
Intensity of pain
7-12 days post-operation patients were examined for intensity of pain
Time frame: 7-12 days post-operation
Investigator's assessment of cosmetic outcome
The Investigator examined patients to assess the cosmetic outcome.
Time frame: At 3 months post-operation
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