Breast CancerAdermbrerecNCT02835781
Acellular Dermal Matrix in Breast Reconstruction
An observational study of Breast Cancer, run by University Hospital Bratislava at 1 site in Slovakia.
Trial summary
Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acellular dermal matrix implantation
- How many people
- 30 participants
- Where
- 1 siteSlovakia
- Study dates
- Jan 2010to Jun 2016
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: The cohort will be selected from patients with breast cancer and in remission, sent to plastic and reconstruction surgery clinics for breast reconstruction after therapeutical mastectomy.
Who may be able to join
- signed informed consent
- total one-side mastectomy due to breast cancer
- age between 18-60 years
Who cannot join
- failure to obtain signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction
Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.
Read the detailed description
This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.
- Conditions
- Breast Cancer
- Being tested
- Acellular dermal matrix implantation
- Keywords
- Breast Implants, Acellular Dermal Matrix
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular dermal matrix implantationOther
Also called breast reconstruction
Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.
| Study group | Role | What they receive |
|---|---|---|
| Acellular dermal matrix arm | The females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation. Receives: Other: Acellular dermal matrix implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
All patients between January 2010 and June 2014 undergoing primary ADM implantation will be evaluated at 6 months after implantation for early ex-plantations, inflammation, deformities of the implants, allergic reactions will be observed in patients undergoing primary ADM implantation at 6 months until second permanent implantation is performed.
Measured: 6 months
Secondary outcomes (2)
Histologic evaluation of ADM implants upon planned explantations
All patients between January 2012 and June 2014 after primary ADM transplantation will be evaluated. Analysis of cell composition, leukocytes at place, vessel formation and dysplasias will be performed
Measured: 6 months
Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire
Physical and psychical as well as sexual well-being with outcome will be evaluated by specifically for this purpose developed questionnaire (The Breast-Q questionnaire) after permanent breast implant implantation at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bratislava
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Julius Hodosy, University Hospital Bratislava
- Investigators
- Miroslav Bdzoch, MD, PhD, Study director, University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835781
- Sponsor's protocol ID
- UHB/006/2015/MB
- Acronym
- Adermbrerec
- Status last verified
- Jul 2016
- First submitted
- 28 Jun 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bohac M, Varga I, Polak S, Dragunova J, Fedeles J Sr, Koller J. Delayed post mastectomy breast reconstructions with allogeneic acellular dermal matrix prepared by a new decellularizationmethod. Cell Tissue Bank. 2018 Mar;19(1):61-68. doi: 10.1007/s10561-017-9655-0. Epub 2017 Aug 16.
PubMed 28812172
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02835781
- Acronym / sponsor ID
- Adermbrerec / UHB/006/2015/MB
- Conditions
- Breast Cancer
- Keywords
- Breast Implants, Acellular Dermal Matrix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital BratislavaUniversity, hospital or other
- Collaborators
- Comenius University
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Jul 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.
Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.
Detailed description
This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acellular dermal matrix arm | – | Other: Acellular dermal matrix implantationThe females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The cohort will be selected from patients with breast cancer and in remission, sent to plastic and reconstruction surgery clinics for breast reconstruction after therapeutical mastectomy.
Key inclusion criteria (3 listed)
- signed informed consent
- total one-side mastectomy due to breast cancer
- age between 18-60 years
Key exclusion criteria (1 listed)
- failure to obtain signed informed consent
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 |
|---|---|---|
| Acellular dermal matrix implantationAlso: breast reconstructionAcellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation. | Other | Acellular dermal matrix arm |
Primary outcome
Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
Time frame: 6 months
All patients between January 2010 and June 2014 undergoing primary ADM implantation will be evaluated at 6 months after implantation for early ex-plantations, inflammation, deformities of the implants, allergic reactions will be observed in patients undergoing primary ADM implantation at 6 months until second permanent implantation is performed.
2 secondary outcomes
Histologic evaluation of ADM implants upon planned explantations
Time frame: 6 months
Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire
Time frame: 2 years
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 18 Jul 2016.
- Derived from this study: PubMed 28812172Bohac M, Varga I, Polak S, Dragunova J, Fedeles J Sr, Koller J. Delayed post mastectomy breast reconstructions with allogeneic acellular dermal matrix prepared by a new decellularizationmethod. Cell Tissue Bank. 2018 Mar;19(1):61-68. doi: 10.1007/s10561-017-9655-0. Epub 2017 Aug 16.
- 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.
Miroslav Bdzoch, MD, PhD study director
University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital Bratislava at 1 site in Slovakia.
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 1 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 18 Jul 2016. 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 Slovakia. 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?
Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation (time frame: 6 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 NCT02835781, which also lists 1 linked publication.
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 18 Jul 2016.