Abdominoplasty
Conditions
Brief summary
Autologous glue therapy with platelet-rich plasma (PRP) was reported to improve outcomes in plastic surgery. However, only pilot studies and retrospective uncontrolled trials have reported the potential benefits of autologous glue treatment up to now. Therefore, a larger, blinded, randomized and placebo-controlled clinical trial would be useful to determine whether platelet-rich plasma is safe and effective in abdominoplasty procedures. Currently, there are pharmacological options such as artificial fibrin glues composed of homologous fibrinogen and animal-derived thrombin. However, these therapeutics present a risk of transmissible diseases and may induce allergic reactions. Therefore, autologous glues, which are fully made of blood components from the patient itself (autologous fibrinogen contained in PRP and autologous thrombin) represents a safe alternative to artificial biological glues. Regen Lab SA developed RegenKit®-Surgery to prepare autologous PRP, on one hand, and an autologous activated thrombin serum, on the other hand, in a safe and rapid manner. RegenKit®-Surgery is a CE-marked class IIb medical device. This study, conducted on 56 patients, will evaluate the effects of autologous glue prepared with RegenKit®-Surgery when used in reconstructive abdominoplasty.
Interventions
DEVICEAutologous glue
Patients will undergo abdominoplasty according to the procedure routinely used in the Department of Plastic, Reconstructive and Aesthetic Surgery of HUG. At the end of the procedure, patients assigned to the experimental group will be additionally treated with an application of autologous glue prepared with RegenKit®-Surgery in the undermining region space between fascia and skin, just before closure of the surgical wound.
Sponsors
Regen Lab SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age with an indication for abdominoplasty * Signature of informed consent form * Capable of understanding the study's imperatives
Exclusion criteria
* Participation -ongoing or in the last two months- in another clinical trial * Pregnancy or breastfeeding * Auto-immune disease (e.g. Hashimoto, rheumatoid arthritis, lupus, etc.) * Hereditary or acquired hematologic disorder (e.g. drepanocytosis, etc.) * Haemoglobin \< 10g/dl * Haematocrit \< 33% * Hereditary or acquired coagulation disorder (e.g. platelet dysfunction syndrome, critical thrombocytopenia with a platelet count \< 150'000/microlitre, impaired coagulation,etc.) * Systemic disorders such as diabetes, or hepatitis * Acute infection * Any active malignancy * Chemotherapy * Refusal or incapacity to give Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to drain removal | Maximum of 10 days | Period of time needed until the drain can be removed after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Volume of exsudates coming from the drain daily | Maximum of 10 days |
| Percentage of patients with post-operative collections after drain removal | 2 weeks after surgery |
| Reoperation rate | 6 months |
| Incidence and severity of adverse events | 6 months |
Contacts
Primary ContactValérie de Fourmestraux, PhD
Outcome results
None listed