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

RegenLab

Status: Unknown

Conditions: Abdominoplasty

Treatments: Device: Autologous glue

Study type: Interventional

Funder types: Industry

Identifiers

NCT02930447

2014-AG-002

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Device: Autologous glue

Control group

No Intervention group

Description:

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.