Clinical trial NCT02179723: Clinical Study Into the Cosmetic Results of Leukosan Adhesive
Official title: Clinical Study Into the Cosmetic Results of Leukosan Adhesive vs. Transcutaneous Wound Suture With Laparoscopic Trocar Incision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing Cosmetic Result
Keywords: wound healing
cosmetic results
trocar incision
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient's satisfaction with cosmetic appearance/result of the wound
timeFrame: 3 months post operation
Secondary outcomes:
measure: The incidence of complication
timeFrame: 7-12 days post-operation
measure: Intensity of pain
timeFrame: 7-12 days post-operation
measure: Investigator's assessment of cosmetic outcome
timeFrame: At 3 months post-operation
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Tagesklinik Altonaer Strasse
Study officials:
affiliation: Tagesklinik Altonaer Strasse
name: Olaf Buchweitz, Priv.Doz.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51. doi: 10.1016/s1074-3804(05)80226-9.
citation: 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. doi: 10.1016/s1072-7515(03)00119-4.
citation: Buchweitz O, Wulfing 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. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.
citation: 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.
citation: 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. doi: 10.1007/BF01068419.
citation: Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.