Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty

Regen Lab SA56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Abdominoplasty

Autologous glueDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to drain removal

Period of time needed until the drain can be removed after surgery

Time frame: Maximum of 10 days

Secondary Outcomes

Volume of exsudates coming from the drain daily

Time frame: Maximum of 10 days

Percentage of patients with post-operative collections after drain removal

Time frame: 2 weeks after surgery

Reoperation rate

Time frame: 6 months

Incidence and severity of adverse events