Post-bariatric surgery, abdominoplasty, lower body lift MedDRA version: 18.0 Level: LLT Classification code 10051609 Term: Postoperative drainage System Organ Class: 100000004863 MedDRA version: 18.0 Level: PT Classification code 10062082 Term: Plastic surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: PT Classification code 10053774 Term: Abdominoplasty System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Artiss
Product Name: Artiss
Pharmaceutical Form: Sealant
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - inoperable from anaesthesiological perspective - increased bleeding tendency (ProTime INR= 38 sec; platelets 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Secondary questions of this trial are the incidence of complications such as seroma, revision surgery and wound infections in both groups and the duration and need for drainage. In addition, the psychological aspects such as quality of life, the quality of interpersonal relationships, psychiatric co-morbidity, and self-esteem before and after the considered body contouring operations in both treatment arms are considered.;Primary end point(s): Reduction of the wound drainage volume;Timepoint(s) of evaluation of this end point: day 1 to day 7 after post-bariatric body contouring operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - proportion of patients with a drainage volume 30 ml - wound drainage volume per day - 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 - quality of interpersonal relationships (Realationship Assessment Scale) - psychiatric comorbidities assessed by the Patient Health Questionnaire - Importance of weight and shape measured by subscales - Self-esteem ( Rosenberg Self-Esteem Scale) and the body image ( Figure Rating Scale) - Assessment of specific surgical issues / problems (such as postoperative pain, recovery process and satisfaction with treatment);Timepoint(s) of evaluation of this end point: - Baseline - Day 1 to Day 7 after after post-bariatric body contouring operation - Follow-up after 12 weeks | — |
Countries
Germany
Contacts
Public ContactIFB Adipositas Data Center
Universität Leipzig, ZKS Leipzig-KKS
Outcome results
None listed