E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-bariatric surgery, abdominoplasty, lower body lift |
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E.1.1.1 | Medical condition in easily understood language |
Post-bariatric surgery, abdominoplasty (tightening the abdomen) and the body-lift (tightening abdomen, buttocks and back) |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051609 |
E.1.2 | Term | Postoperative drainage |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062082 |
E.1.2 | Term | Plastic surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053774 |
E.1.2 | Term | Abdominoplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of the wound drainage volume |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
day 1 to day 7 after post-bariatric body contouring operation |
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E.5.2 | Secondary end point(s) |
- proportion of patients with a drainage volume <30 ml/day from the first day after surgery - number of “drainage days” - number of days 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) |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard procedure (wound closure after abdominoplasty / lower body lift ) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |