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

Sponsor
Regen Lab SA (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT02930447
Collaborator
(none)
56
Enrollment
2
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Autologous glue
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Time to drain removal [Maximum of 10 days]

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

Secondary Outcome Measures

  1. Volume of exsudates coming from the drain daily [Maximum of 10 days]

  2. Percentage of patients with post-operative collections after drain removal [2 weeks after surgery]

  3. Reoperation rate [6 months]

  4. Incidence and severity of adverse events [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Regen Lab SA

Investigators

  • Principal Investigator: Ali Modarressi, MD, Hôpitaux Universitaires de Genève

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regen Lab SA
ClinicalTrials.gov Identifier:
NCT02930447
Other Study ID Numbers:
  • 2014-AG-002
First Posted:
Oct 12, 2016
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 14, 2019