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

Not Applicable

• Conditions: Abdominoplasty
• Interventions: Device: Autologous glue

• Registration Number: NCT02930447
• Lead Sponsor: Regen Lab SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14
• Study Start: 2021-01
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Autologous glue	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.

Primary Outcome Measures

Name	Time	Method
Time to drain removal	Maximum of 10 days	Period of time needed until the drain can be removed after surgery

Secondary Outcome Measures

Name	Time	Method
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