Breast CancerNCT04209010
Immediate Breast Reconstruction With Acellular Dermal Matrix
An observational study of Breast Cancer and Breast Carcinoma in Situ, run by Aarhus University Hospital.
Trial summary
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma in Situ, Mammaplasty
- What is being tested?
- one-stage technique
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 17 Mar 2016
- How long will I take part?
- 2 Years
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients were all women admitted for immediate, implant-based breast reconstruction following skin-sparing mastectomy at the Department of Plastic and Breast Surgery, Aarhus University Hospital, Denmark from September 2010 to January 2014.
Who may be able to join
- Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
- Mastectomy weight ≤ 600 g
- Patient older than 18 years
- Ability to complete the study questionnaire
- Only for the two-stage group no later than 2 years and 4 months from breast reconstruction
Who cannot join
- smokers
About this study
Official title: Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.
- Conditions
- Breast Cancer, Breast Carcinoma in Situ, Mammaplasty, Acellular Dermis
- Being tested
- one-stage technique
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-stage techniqueProcedure or surgery
breast reconstruction in one stage using silicone implant and acellular dermal matrix.
| Study group | Role | What they receive |
|---|---|---|
| One-stage group | Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix. Receives: Procedure: one-stage technique | |
| Two-stage group | Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.
Measured: 3 months
Postoperative complications
Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.
Measured: 3 months
Secondary outcomes (4)
Patient assessed satisfaction with aesthetic result
Assessment of result with and without clothes, symmetry and all-in-all satisfaction with result. Obtained by questionnaire on a 7 point Likert scale. Higher score equals higher satisfaction.
Measured: 2 years
Investigator assessed satisfaction with aesthetic result
Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination.
Measured: 2 years
Patient reported outcome measures
Patient reported assessment of pain and dysaesthesia in reconstructed breast, arm/shoulder function on reconstructed side. Described on a 6 point scale where lower score equals more pain/dysaesthesia/troubles with arm/shoulder function.
Body image (Hopwoods Body Image Scale) assessed in a 10-items each on 4 point Likert scale from 0 to 3. Sum provides a total score (range 0-30) and lower scores equals less body image troubles.
Furthermore, study specific questions as "use of pain killers the last week" (yes / no) and "all in all assessment of health owning to the breast reconstruction" (improved / diminished or unchanged). All obtained by questionnaire.
Measured: 2 years
Cost
cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions.
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 posted23 Dec 2019
- Study start1 Dec 2012
- Primary completion17 Mar 2016
- Study completion17 Mar 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
- 44 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, The Korning foundation, Foundation of the Kjaersgaard Family, King Christian X foundation, Foundation of architect Holger Hjortenberg, LifeCell Corporation (Branchburg, NJ, USA)
- Responsible party
- Principal investigator, Mette Eline Brunbjerg, MD, Aarhus University Hospital
- Investigators
- Mette Eline Brunbjerg, MD, Principal investigator, Aarhus University Hospital, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209010
- Sponsor's protocol ID
- VEK 1-10-72-572-12
- Status last verified
- Jan 2020
- First submitted
- 17 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymized.
Publications
Brunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581.
PubMed 33633977
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study
- ClinicalTrials.gov ID
- NCT04209010
- Acronym / sponsor ID
- VEK 1-10-72-572-12
- Conditions
- Breast Cancer, Breast Carcinoma in Situ, Mammaplasty, Acellular Dermis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society, The Korning foundation, Foundation of the Kjaersgaard Family, King Christian X foundation, Foundation of architect Holger Hjortenberg, LifeCell Corporation (Branchburg, NJ, USA)
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 17 Mar 2016 (actual)
- Study completion
- 17 Mar 2016 (actual)
- First posted
- 23 Dec 2019 (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.
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-stage group | – | Procedure: one-stage techniqueImmediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix. |
| Two-stage group | – | –Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients were all women admitted for immediate, implant-based breast reconstruction following skin-sparing mastectomy at the Department of Plastic and Breast Surgery, Aarhus University Hospital, Denmark from September 2010 to January 2014.
Key inclusion criteria (5 listed)
- Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
- Mastectomy weight ≤ 600 g
- Patient older than 18 years
- Ability to complete the study questionnaire
- Only for the two-stage group no later than 2 years and 4 months from breast reconstruction
Key exclusion criteria (1 listed)
- smokers
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 |
|---|---|---|
| one-stage techniquebreast reconstruction in one stage using silicone implant and acellular dermal matrix. | Procedure or surgery | One-stage group |
Primary outcome
Postoperative complications
Time frame: 3 months
Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.
Postoperative complications
Time frame: 3 months
Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.
4 secondary outcomes
Patient assessed satisfaction with aesthetic result
Time frame: 2 years
Investigator assessed satisfaction with aesthetic result
Time frame: 2 years
Patient reported outcome measures
Time frame: 2 years
Cost
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 3 Jan 2020.
- Derived from this study: PubMed 33633977Brunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581.
- Individual participant dataSharing planned: No. All data will be anonymized.
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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.
Mette Eline Brunbjerg, MD principal investigator
Aarhus University Hospital, Aarhus University, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Carcinoma in Situ, run by Aarhus University Hospital.
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 5 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 3 Jan 2020. 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?
Postoperative complications (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04209010, 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 3 Jan 2020.