AbdominoplastyNCT02930447
Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
A study testing Autologous glue in people with Abdominoplasty, run by Regen Lab SA.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Autologous glue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with an indication for abdominoplasty
- Signature of informed consent form
- Capable of understanding the study's imperatives
Who cannot join
- 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%
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- Autologous glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous glueDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to drain removal
Period of time needed until the drain can be removed after surgery
Measured: Maximum of 10 days
Secondary outcomes (4)
Volume of exsudates coming from the drain daily
Measured: Maximum of 10 days
Percentage of patients with post-operative collections after drain removal
Measured: 2 weeks after surgery
Reoperation rate
Measured: 6 months
Incidence and severity of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Modarressi, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930447
- Sponsor's protocol ID
- 2014-AG-002
- Status last verified
- Nov 2019
- First submitted
- 10 Oct 2016
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Study to Evaluate the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty
- ClinicalTrials.gov ID
- NCT02930447
- Acronym / sponsor ID
- 2014-AG-002
- Conditions
- Abdominoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Autologous glueAutologous 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age with an indication for abdominoplasty
- Signature of informed consent form
- Capable of understanding the study's imperatives
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous gluePatients 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. | Device | Treatment group |
Primary outcome
Time to drain removal
Time frame: Maximum of 10 days
Period of time needed until the drain can be removed after surgery
4 secondary outcomes
Volume of exsudates coming from the drain daily
Time frame: Maximum of 10 days
Percentage of patients with post-operative collections after drain removal
Time frame: 2 weeks after surgery
Reoperation rate
Time frame: 6 months
Incidence and severity of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Modarressi, MD principal investigator
University Hospital, Geneva
Questions about this trial
What is this clinical trial studying?
A study testing Autologous glue in people with Abdominoplasty, run by Regen Lab SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie de Fourmestraux, PhD (+41(0)218640110 ext. 118, vdefourmestraux@regenlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to drain removal (time frame: Maximum of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.