Wound Management in Post-Bariatric SurgeryInvestigation for the reduction of the mean drainage volume in patients after abdominoplasty (tightening the abdomen)/ lower body lift (tightening abdomen, buttocks and back) using Artiss Fibrin Sealant in comparison to the standard procedure

Phase 1

• Conditions: MedDRA version: 18.0Level: PTClassification code 10062082Term: Plastic surgerySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: PTClassification code 10053774Term: AbdominoplastySystem Organ Class: 10042613 - Surgical and medical procedures; Post-bariatric surgery, abdominoplasty, lower body lift; MedDRA version: 18.0Level: LLTClassification code 10051609Term: Postoperative drainageSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2013-004353-24-DE
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Study Completion: 2017-03-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>The primary endpoint in the volume of wound drainage fluid.<br>;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.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): - proportion of patients with a drainage volume <30 ml/day from the first day after surgery<br>- number of drainage days”<br>- number of days with a drainage volume >30 ml<br>- wound drainage volume per day<br>- length of in-hospital stay<br>- quality of life measured by Impact of Weight in Quality of Life, Post-Bariatric-Surgery Quality of Life and Weight Bias Internalization Scale<br>- quality of interpersonal relationships (Realationship Assessment Scale)<br>- psychiatric comorbidities assessed by the Patient Health Questionnaire<br>- Importance of weight and shape measured by subscales<br>- Self-esteem ( Rosenberg Self-Esteem Scale) and the body image ( Figure Rating Scale)<br>- 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<br>- Day 1 to Day 7 after after post-bariatric body contouring operation<br>- Follow-up after 12 weeks