Clinical Study Into the Cosmetic Results of Leukosan Adhesive
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Leukosan Adhesive Leukosan Adhesive applied to one wound (left or right) |
Device: Leukosan Adhesive
Leukosan adhesive applied to one wound
Device: Transcutaneous suture
Transcutaneous suture applied to one wound
|
| Active Comparator: Transcutaneous suture Transcutaneous suture applied to second wound (left or right) |
Device: Leukosan Adhesive
Leukosan adhesive applied to one wound
Device: Transcutaneous suture
Transcutaneous suture applied to one wound
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tagesklinik Altonaer Strasse | Hamburg | Germany | 20357 |
Sponsors and Collaborators
- Dr. Stephanie Krause
Investigators
- Principal Investigator: Olaf Buchweitz, Priv.Doz., Tagesklinik Altonaer Strasse
Study Documents (Full-Text)
None provided.More Information
Publications
- Buchweitz O, Wülfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. Epub 2004 Nov 18.
- Chen K, Klapper AS, Voige H, Del Priore G. A randomized, controlled study comparing two standardized closure methods of laparoscopic port sites. JSLS. 2010 Jul-Sep;14(3):391-4. doi: 10.4293/108680810X12924466006729.
- Matin SF. Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions. J Am Coll Surg. 2003 Jun;196(6):845-53.
- Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51.
- Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80.
- BSNMedicalC09962
- PV4003