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

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

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 Overview

• Status: Unknown
• Conditions: Abdominoplasty
• Intervention / Treatment: Device: Autologous glue

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group; 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; 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.
NO_INTERVENTION: Control group; 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?

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	Time Frame
Incidence and severity of adverse events	6 months
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

Collaborators and Investigators

• Sponsor: Regen Lab SA
• Investigators: Principal Investigator: Ali Modarressi, MD, Hôpitaux universitaires de Genève

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (ESTIMATE): October 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2014-AG-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No