Clinical Study Into the Cosmetic Results of Leukosan Adhesive

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing Cosmetic Result
• Intervention / Treatment: Device: Leukosan Adhesive; Device: Transcutaneous suture

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20357
    • Tagesklinik Altonaer Strasse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Stephanie Krause
• Investigators: Principal Investigator: Olaf Buchweitz, Priv.Doz., Tagesklinik Altonaer Strasse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: wound healing; cosmetic results; trocar incision
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: BSNMedicalC09962; PV4003 (Other Identifier: Ethik Kommission der Aerztekammer Hamburg)