Clinical trial NCT02930447: Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
Official title: Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominoplasty
Lead sponsor: Regen Lab SA
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to drain removal
timeFrame: Maximum of 10 days
Secondary outcomes:
measure: Volume of exsudates coming from the drain daily
timeFrame: Maximum of 10 days
measure: Percentage of patients with post-operative collections after drain removal
timeFrame: 2 weeks after surgery
measure: Reoperation rate
timeFrame: 6 months
measure: Incidence and severity of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Geneva
name: Ali Modarressi, MD
role: PRINCIPAL_INVESTIGATOR
References: