EUCTR2013-004353-24-DEActive, not recruitingPhase 1
Wound Management in Post-Bariatric SurgeryInvestigation 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
niversität Leipzig0 sites18 target enrollmentStarted: January 23, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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)
Investigators
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