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

Phase 4

• Conditions: Obesity, abdominoplasty/lower body lift after bariatric surgery; Z41; Procedures for purposes other than remedying health state

• Registration Number: DRKS00006178
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-20
• Study Completion: 2017-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the wound drainage volume until 14 days after surgery