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

Abdominoplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02930447
• Other study ID #: 2014-AG-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2019
• Source: Regen Lab SA
• Contact: Valérie de Fourmestraux, PhD
• Phone: +41(0)218640110
• Email: vdefourmestraux[@]regenlab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominoplasty

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regen Lab SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to drain removal	Period of time needed until the drain can be removed after surgery	Maximum of 10 days
Secondary	Volume of exsudates coming from the drain daily		Maximum of 10 days
Secondary	Percentage of patients with post-operative collections after drain removal		2 weeks after surgery
Secondary	Reoperation rate		6 months
Secondary	Incidence and severity of adverse events		6 months