Deep Inferior Epigastric Perforator Flap ReconstructionNCT03481140
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
An observational study of Deep Inferior Epigastric Perforator Flap Reconstruction, run by Cohera Medical, Inc..
Trial summary
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Inferior Epigastric Perforator Flap Reconstruction
- What is being tested?
- TissuGlu Surgical Adhesive
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2015to 30 Nov 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a DIEP flap breast reconstruction at the Sana Klinik in Düsseldorf, Germany.
Who may be able to join
- be 18 years of age or older
- be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
- have a body mass index (BMI) < 28
- have received a DIEP flap breast reconstruction procedure
Who cannot join
- current smoker
- have a body mass index (BMI) > 28
- taking active SSRI medication prescriptions
About this study
Official title: Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.
- Being tested
- TissuGlu Surgical Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuGlu Surgical AdhesiveDevice
lysine-derived urethane adhesive
| Study group | Role | What they receive |
|---|---|---|
| Control | donor site DIEP flap breast reconstruction procedure with standard wound closure with drains | |
| TissuGlu Surgical Adhesive | donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains Receives: Device: TissuGlu Surgical Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of post-operative clinical interventions related to wound fluid management at the donor site
number of interventions
Measured: 6 weeks post-operatively
Secondary outcomes (5)
total wound drainage
drain volume + aspiration volume
Measured: 6 weeks post-operatively
cumulative drain volume
volume
Measured: 6 weeks post-operatively
aspiration volume
volume
Measured: 6 weeks post-operatively
cumulative days of invasive treatment
days with drains in + days in which an aspiration was performed
Measured: 6 weeks post-operatively
days to drain removal
days
Measured: 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start21 Apr 2015
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Inferior Epigastric Perforator Flap ReconstructionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cohera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481140
- Sponsor's protocol ID
- CLN-100-0024
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients
- ClinicalTrials.gov ID
- NCT03481140
- Acronym / sponsor ID
- CLN-100-0024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cohera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2015
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –donor site DIEP flap breast reconstruction procedure with standard wound closure with drains |
| TissuGlu Surgical Adhesive | – | Device: TissuGlu Surgical Adhesivedonor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a DIEP flap breast reconstruction at the Sana Klinik in Düsseldorf, Germany.
Key inclusion criteria (4 listed)
- be 18 years of age or older
- be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
- have a body mass index (BMI) < 28
- have received a DIEP flap breast reconstruction procedure
Key exclusion criteria (3 listed)
- current smoker
- have a body mass index (BMI) > 28
- taking active SSRI medication prescriptions
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 |
|---|---|---|
| TissuGlu Surgical Adhesivelysine-derived urethane adhesive | Device | TissuGlu Surgical Adhesive |
Primary outcome
number of post-operative clinical interventions related to wound fluid management at the donor site
Time frame: 6 weeks post-operatively
number of interventions
5 secondary outcomes
total wound drainage
Time frame: 6 weeks post-operatively
cumulative drain volume
Time frame: 6 weeks post-operatively
aspiration volume
Time frame: 6 weeks post-operatively
cumulative days of invasive treatment
Time frame: 6 weeks post-operatively
days to drain removal
Time frame: 6 weeks post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Inferior Epigastric Perforator Flap Reconstruction, run by Cohera Medical, Inc..
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of post-operative clinical interventions related to wound fluid management at the donor site (time frame: 6 weeks post-operatively). 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 29 Mar 2018.