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

NCT02930447 | Unknown

• 1 other identifier: 2014-AG-002
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Time to drain removal

  Period of time needed until the drain can be removed after surgery

  Maximum of 10 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Autologous glue DEVICE

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.

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with an indication for abdominoplasty
• Signature of informed consent form
• Capable of understanding the study's imperatives

You may not qualify if:

• 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

Sponsors & Collaborators

• Regen Lab SA: lead

Study Officials

• Ali Modarressi, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie de Fourmestraux, PhD

CONTACT

+41(0)218640110; vdefourmestraux@regenlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 14, 2019

Record last verified: 2019-11