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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty

Conditions
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Abdominoplasty

Intervention / Treatment
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* Device: Autologous glue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Autologous glue will be prepared from the patient's own blood with RegenKit®-Surgery device and applied per-operatively by spraying in the undermining region space between fascia and skin. | Device: Autologous glue<br>* 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.<br>|
| No Intervention: Control group<br>Patient from the control group will undergo abdominoplasty according to an identical procedure, but without application of autologous glue or any other treatment product before wound closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to drain removal | Period of time needed until the drain can be removed after surgery | Maximum of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |