Breast CancerNCT02985073
A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
A study testing Veritas® and TIGR® in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Veritas® and TIGR®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Sep 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed breast cancer gene mutation or a calculated increased risk > 20% of developing a breast cancer during her lifetime.
Who cannot join
- All patients that don't fulfill criteria above
- Previous breast surgery
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept . of plastic surgery
Gothenburg, Västra Götaland County, 41345
About this study
Official title: The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.
Read the detailed description
The scientific evidence using different types of mesh in breast reconstruction is low at present with very few randomized controlled studies.
This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with bilateral immediate breast reconstruction regarding implant loss rate,infections,total complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.
The patients will be enrolled to the study and sign an informed consent. At the operating theater the patient is randomized either to be reconstructed with Veritas® in one breast and TIGR® in the other breast..
The patients will be followed up according to a specified schedule until one year postoperatively as above.
- Conditions
- Breast Cancer
- Being tested
- Veritas®, TIGR®
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veritas®Device
Biologic mesh
TIGR®Device
Non biologic mesh
| Study group | Role | What they receive |
|---|---|---|
| Veritas® mesh | Experimental | Use of Veritas mesh in conjunction with immediate breast reconstruction on one side Receives: Device: Veritas® |
| TIGR® mesh | Experimental | Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side Receives: Device: TIGR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total complication rate
Total complication rate within one year from surgery
Measured: 12 months
Secondary outcomes (4)
Total infection rate
Total infection rate within 30 days from surgery
Measured: 30 days
Total implant loss rate
Total implant loss rate within one year from surgery
Measured: 12 months
Aesthetic outcome
Aesthetic outcome at one year followup will be assessed by analysis of 3-dimensional pre- and post-op pictures in combination with a panel evaluating different aesthetical units of the breast
Measured: 12 months
HQOL
Three validated questionaries will be used to assess HQOL: EQ-5D,HAD30 and BreastQ. The patient fills in these preoperatively and one year postop
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2020
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lars Kölby, Principal investigator, Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985073
- Sponsor's protocol ID
- 189-16
- Status last verified
- Oct 2022
- First submitted
- 30 Nov 2016
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.
PubMed 31859575Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921. Epub 2020 Jun 9.
PubMed 32515840Hansson E, Edvinsson AC, Elander A, Kolby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10.1002/jso.26227. Epub 2020 Oct 13.
PubMed 33051871Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.
PubMed 36154981
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02985073
- Acronym / sponsor ID
- 189-16
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Nov 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 7 Dec 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.
This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.
Detailed description
The scientific evidence using different types of mesh in breast reconstruction is low at present with very few randomized controlled studies.
This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with bilateral immediate breast reconstruction regarding implant loss rate,infections,total complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.
The patients will be enrolled to the study and sign an informed consent. At the operating theater the patient is randomized either to be reconstructed with Veritas® in one breast and TIGR® in the other breast..
The patients will be followed up according to a specified schedule until one year postoperatively as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veritas® mesh | Experimental | Device: Veritas®Use of Veritas mesh in conjunction with immediate breast reconstruction on one side |
| TIGR® mesh | Experimental | Device: TIGR®Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed breast cancer gene mutation or a calculated increased risk > 20% of developing a breast cancer during her lifetime.
Key exclusion criteria (2 listed)
- All patients that don't fulfill criteria above
- Previous breast surgery
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 |
|---|---|---|
| Veritas®Biologic mesh | Device | Veritas® mesh |
| TIGR®Non biologic mesh | Device | TIGR® mesh |
Primary outcome
Total complication rate
Time frame: 12 months
Total complication rate within one year from surgery
4 secondary outcomes
Total infection rate
Time frame: 30 days
Total implant loss rate
Time frame: 12 months
Aesthetic outcome
Time frame: 12 months
HQOL
Time frame: 12 months
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 17 Oct 2022.
- Results publication: PubMed 31859575Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.
- Results publication: PubMed 32515840Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921. Epub 2020 Jun 9.
- Results publication: PubMed 33051871Hansson E, Edvinsson AC, Elander A, Kolby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10.1002/jso.26227. Epub 2020 Oct 13.
- Results publication: PubMed 36154981Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.
- Full text articleLink provided by the sponsor.
- Full text articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lars Kölby principal investigator
Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veritas® and TIGR® in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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 1 inclusion and 2 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 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Total complication rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985073, which also lists 4 linked publications.
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 17 Oct 2022.