Trial document




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  DRKS00006178

Trial Description

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Title

Wound Management in Post-Bariatric Surgery
Investigation for the reduction of the mean drainage volume in patients after abdominoplasty / lower body lift using Artiss Fibrin Sealant in comparison to the standard procedure

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Trial Acronym

WMPS

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URL of the Trial

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Brief Summary in Lay Language

Many patients who have undergone bariatric surgery develop extreme amounts of excess skin due to the pronounced weight loss. This can be corrected using body contouring operations such as abdominoplasty (tightening the abdomen) and the body-lift (tightening abdomen, buttocks and back). When the wound is closed in such operations, the trial will make use of a fibrin sealant to affix tissue layers. The expectation is that the use of the fibrin sealant will reduce the volume of drainage fluid and prevent seroma (a pocket in which lymphatic fluid or serum collects) as compared to the control group.

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Brief Summary in Scientific Language

The aim of the trial is to assess the effectiveness of the Artiss™ fibrin sealant compared to the standard technique in reducing the volume of wound drainage fluid in patients that have undergone a planned post-bariatric body contouring operation.
The primary endpoint in the volume of wound drainage fluid.

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Organizational Data

  •   DRKS00006178
  •   2014/05/20
  •   2014/01/23
  •   yes
  •   Approved
  •   087-14-10032014, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   2013-004353-24 
  •   EUCTR2013-004353-24-DE  (EUDRA-CT-Datenbank)
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Health Condition or Problem studied

  •   Obesity, abdominoplasty/lower body lift after bariatric surgery
  •   Z41 -  Procedures for purposes other than remedying health state
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Interventions/Observational Groups

  •   abdominoplasty / lower body lift using Artiss Fibrin Sealant
  •   Standard abdominoplasty / lower body lift
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Reduction of the wound drainage volume until 14 days after surgery

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Secondary Outcome

- proportion of patients with a drainage volume <30 ml/day from the first day until 14 days after surgery
- number of “drainage days” until 14 days after surgery
- number of days with a drainage volume >30 ml until 14 days after surgery
- wound drainage volume per day until 14 days after surgery
- length of in-hospital stay
- quality of life measured by Impact of Weight in Quality of Life, Post-Bariatric-Surgery Quality of Life and Weight Bias Internalization Scale to baseline and 12 weeks after surgery
- quality of interpersonal relationships (Realationship Assessment Scale) to baseline and 12 weeks after surgery
- psychiatric comorbidities assessed by the Patient Health Questionnaire to baseline and 12 weeks after surgery
- Importance of weight and shape measured by subscales to baseline and 12 weeks after surgery
- Self-esteem ( Rosenberg Self-Esteem Scale) and the body image ( Figure Rating Scale) to baseline and 12 weeks after surgery
- Assessment of specific surgical issues / problems (such as postoperative pain, recovery process and satisfaction with treatment) to baseline and 12 weeks after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/08/08
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- age of 18 to 65 years
- Previous bariatric surgery with reaching an equilibrium plateau over 6 months
- planned abdominoplasty / lower body lift
- estmated resection weight >1 kg
- Written informed consent

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Exclusion Criteria

- inoperable from anaesthesiological perspective
- increased bleeding tendency (ProTime INR<= 70%; PTT >= 38 sec; platelets <= 150.000/mm³)
- instable diabetes mellitus typ II (HbA1c >8%)
- known complications after blood transfusion (especially AB0 incompatibility reaction, Rh incompatibility reaction)
- known hypersensitivity to human fibrin, aprotinin, human thrombin, L-histidine, niacinamide
- Women during pregnancy and lactation (positive pregnancy test in women of childbearing age)
- Participation in other clinical trials

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Addresses

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    • Universität Leipzig
    • Ritterstr. 26
    • 04109  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöRDepartment für operative Medizin (DOPM)Abteilung für Plastische, Ästhetische und spezielle Handchirurgie
    • Mr.  Prof. Dr. med.  Stefan  Langer 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig - AöRDepartment für Operative Medizin (DOPM)Abteilung für Plastische, Ästhetische und Spezielle Handchirurgie
    • Mr.  Prof. Dr. med.  Stefan  Langer 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • BMBF IFB Adipositas-Erkrankungen
    • Liebigstr. 21
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2017/03/03
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Trial Publications, Results and other Documents

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