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Clinical Study Into the Cosmetic Results of Leukosan Adhesive

Primary Purpose

Wound Healing Cosmetic Result

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Leukosan Adhesive
Transcutaneous suture
Sponsored by
Dr. Stephanie Krause
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing Cosmetic Result focused on measuring wound healing, cosmetic results, trocar incision

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tagesklinik Altonaer Strasse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Leukosan Adhesive

Transcutaneous suture

Arm Description

Leukosan Adhesive applied to one wound (left or right)

Transcutaneous suture applied to second wound (left or right)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Intensity of pain
7-12 days post-operation patients were examined for intensity of pain
Investigator's assessment of cosmetic outcome
The Investigator examined patients to assess the cosmetic outcome.

Full Information

First Posted
June 30, 2014
Last Updated
June 30, 2014
Sponsor
Dr. Stephanie Krause
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1. Study Identification

Unique Protocol Identification Number
NCT02179723
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Stephanie Krause

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing Cosmetic Result
Keywords
wound healing, cosmetic results, trocar incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leukosan Adhesive
Arm Type
Experimental
Arm Description
Leukosan Adhesive applied to one wound (left or right)
Arm Title
Transcutaneous suture
Arm Type
Active Comparator
Arm Description
Transcutaneous suture applied to second wound (left or right)
Intervention Type
Device
Intervention Name(s)
Leukosan Adhesive
Intervention Description
Leukosan adhesive applied to one wound
Intervention Type
Device
Intervention Name(s)
Transcutaneous suture
Intervention Description
Transcutaneous suture applied to one wound
Primary Outcome Measure Information:
Title
Patient's satisfaction with cosmetic appearance/result of the wound
Description
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
Secondary Outcome Measure Information:
Title
The incidence of complication
Description
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
Title
Intensity of pain
Description
7-12 days post-operation patients were examined for intensity of pain
Time Frame
7-12 days post-operation
Title
Investigator's assessment of cosmetic outcome
Description
The Investigator examined patients to assess the cosmetic outcome.
Time Frame
At 3 months post-operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Buchweitz, Priv.Doz.
Organizational Affiliation
Tagesklinik Altonaer Strasse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tagesklinik Altonaer Strasse
City
Hamburg
ZIP/Postal Code
20357
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
9154784
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.
Results Reference
background
PubMed Identifier
12788419
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.
Results Reference
background
PubMed Identifier
15549624
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.
Results Reference
background
PubMed Identifier
21333194
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.
Results Reference
background
PubMed Identifier
3450848
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.
Results Reference
background
PubMed Identifier
26428200
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.
Results Reference
derived

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Clinical Study Into the Cosmetic Results of Leukosan Adhesive

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