Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008338

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00008338
  •   2016/02/19
  •   2014/06/30
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02179723  (ClinicalTrials.gov)
  •   BSNMedicalC09962  (Dr. Stephanie Krause)
  •   PV4003 
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Health Condition or Problem studied

  •   Wound Healing Cosmetic Result
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Interventions/Observational Groups

  •   Device: Leukosan Adhesive
  •   Device: Transcutaneous suture
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

- Patient's satisfaction with cosmetic appearance/result of the wound; time frame: 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.

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Secondary Outcome

- The incidence of complication; time frame: 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; time frame: 7-12 days post-operation; 7-12 days post-operation patients were examined for intensity of pain
- Investigator's assessment of cosmetic outcome; time frame: At 3 months post-operation; The Investigator examined patients to assess the cosmetic outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2012/03/31
  •   77
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Inclusion Criteria

  •   Female
  •   18   Years
  •   60   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. Stephanie Krause
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    • Tagesklinik Altonaer Strasse
    • Olaf Buchweitz, Priv.Doz. 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Tagesklinik Altonaer Strasse
    • Olaf Buchweitz, Priv.Doz. 
    end of 1:1-Block address public-contact
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/07/01
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Trial Publications, Results and other Documents

  •   Rosen DM, Carlton MA. Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):347-51.; 9154784
  •   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.; 12788419
  •   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.; 15549624
  •   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.; 3450848
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.