Breast CancerAllodermRCTNCT00956384
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
A study testing One-stage dermal matrix/implant procedure and Two-stage tissue expander/implant procedure in people with Breast Cancer, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- One-stage dermal matrix/implant procedure and Two-stage tissue expander/implant procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Sep 2009to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who undergo immediate, implant-based reconstruction following skin-sparing and nipple-sparing mastectomy.
- Patients who are older than 18 years of age and who understand English enough to complete the study questionnaires.
Who cannot join
- Patient refusal, patients with documented psychiatric history of psychosis or mental disorder excluding depression, patients who are active smokers.
- Patients who will undergo any of the following: Autologous tissue reconstruction, patients with prior history of radiation or expected to receive post-operative radiation, patients who are pregnant, patients with grade III ptosis.
- Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or have significant ischemia.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Plastic Surgery, Women's College Hospital
Toronto, Ontario, M5G 1N8
Plastic and Reconstructive Surgery, University Health Network
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
Read the detailed description
Recently, there has been significant focus on the performance of skin-sparing mastectomies in certain types of breast cancer patients. These treatments may be performed for prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy, however there are significant disadvantages as this technique requires two separate surgeries and multiple office visits to complete that may affect a patients quality of life. Medically safe compounds such as acellular dermal matrix have been developed that have the potential to support breast implants without requiring numerous tissue expansions and consequently providing the potential for a one-stage breast implant/reconstruction procedure for immediate, skin-sparing mastectomies.
To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 \& 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-stage breast reconstruction is superior to that following the standard two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy patients.
To determine the short and long-term operative complication rates associated with the use of dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast reconstruction is associated with decreased short and long-term postoperative complications compared with the traditional two staged tissue expander/implant procedure.
- Conditions
- Breast Cancer
- Being tested
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Keywords
- Breast reconstruction, Early stage, Skin-saving mastectomy, Prophylactic mastectomy, Acellular dermal matrix, BRCA Mutation Carriers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-stage dermal matrix/implant procedureProcedure or surgery
Also called Alloderm
One-stage breast reconstruction with dermal matrix and implant
Two-stage tissue expander/implant procedureProcedure or surgery
Two-stage breast reconstruction with tissue expander and implant
| Study group | Role | What they receive |
|---|---|---|
| One-stage dermal matrix/implant | Experimental | One-stage breast reconstruction with dermal matrix and implant Receives: Procedure: One-stage dermal matrix/implant procedure |
| Two-stage tissue expander/implant | Active comparator | Two-stage breast reconstruction with tissue expander and implant Receives: Procedure: Two-stage tissue expander/implant procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BreastQ Quality of Life and Satisfaction Questionnaire
Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module.
The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.
Measured: 12 months post-op
Secondary outcomes (2)
Number of Participants With Short Term Surgical Complications
Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery
Measured: 6- months post-op
Number of Participants With Long Term Surgical Complications
Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study start1 Sep 2009
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 University Health Network, TorontoThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, Vancouver General Hospital, Canadian Breast Cancer Foundation, Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Toni Zhong, MD FRCS(C), Principal investigator, University Health Network, TorontoMitchell Brown, MD FRCS(C), Principal investigator, Women's College HospitalStefan Hofer, MD FRCS(C), Principal investigator, University Health Network, TorontoJohn Semple, MD FRCS(C), Principal investigator, Women's College HospitalBrett Beber, MD FRCS(C), Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956384
- Sponsor's protocol ID
- PSEF-137034
- Acronym
- AllodermRCT
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2009
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zhong T, Temple-Oberle C, Hofer SO, Beber B, Semple J, Brown M, Macadam S, Lennox P, Panzarella T, McCarthy C, Baxter N; MCCAT Study Group. The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction. Trials. 2013 Oct 28;14:356. doi: 10.1186/1745-6215-14-356.
PubMed 24165392
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
- ClinicalTrials.gov ID
- NCT00956384
- Acronym / sponsor ID
- AllodermRCT / PSEF-137034
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, Early stage, Skin-saving mastectomy, Prophylactic mastectomy, Acellular dermal matrix, BRCA Mutation Carriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Women's College Hospital, Vancouver General Hospital, Canadian Breast Cancer Foundation, Tom Baker Cancer Centre
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
Detailed description
Recently, there has been significant focus on the performance of skin-sparing mastectomies in certain types of breast cancer patients. These treatments may be performed for prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy, however there are significant disadvantages as this technique requires two separate surgeries and multiple office visits to complete that may affect a patients quality of life. Medically safe compounds such as acellular dermal matrix have been developed that have the potential to support breast implants without requiring numerous tissue expansions and consequently providing the potential for a one-stage breast implant/reconstruction procedure for immediate, skin-sparing mastectomies.
To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 \& 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-stage breast reconstruction is superior to that following the standard two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy patients.
To determine the short and long-term operative complication rates associated with the use of dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast reconstruction is associated with decreased short and long-term postoperative complications compared with the traditional two staged tissue expander/implant procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-stage dermal matrix/implant | Experimental | Procedure: One-stage dermal matrix/implant procedureOne-stage breast reconstruction with dermal matrix and implant |
| Two-stage tissue expander/implant | Active comparator | Procedure: Two-stage tissue expander/implant procedureTwo-stage breast reconstruction with tissue expander and implant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo immediate, implant-based reconstruction following skin-sparing and nipple-sparing mastectomy.
- Patients who are older than 18 years of age and who understand English enough to complete the study questionnaires.
Key exclusion criteria (3 listed)
- Patient refusal, patients with documented psychiatric history of psychosis or mental disorder excluding depression, patients who are active smokers.
- Patients who will undergo any of the following: Autologous tissue reconstruction, patients with prior history of radiation or expected to receive post-operative radiation, patients who are pregnant, patients with grade III ptosis.
- Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or have significant ischemia.
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 dermal matrix/implant procedureAlso: AllodermOne-stage breast reconstruction with dermal matrix and implant | Procedure or surgery | One-stage dermal matrix/implant |
| Two-stage tissue expander/implant procedureTwo-stage breast reconstruction with tissue expander and implant | Procedure or surgery | Two-stage tissue expander/implant |
Primary outcome
BreastQ Quality of Life and Satisfaction Questionnaire
Time frame: 12 months post-op
Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.
2 secondary outcomes
Number of Participants With Short Term Surgical Complications
Time frame: 6- months post-op
Number of Participants With Long Term Surgical Complications
Time frame: 12 months post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24165392Zhong T, Temple-Oberle C, Hofer SO, Beber B, Semple J, Brown M, Macadam S, Lennox P, Panzarella T, McCarthy C, Baxter N; MCCAT Study Group. The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction. Trials. 2013 Oct 28;14:356. doi: 10.1186/1745-6215-14-356.
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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.
Toni Zhong, MD FRCS(C) principal investigator
University Health Network, Toronto
Mitchell Brown, MD FRCS(C) principal investigator
Women's College Hospital
Stefan Hofer, MD FRCS(C) principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-stage dermal matrix/implant procedure and Two-stage tissue expander/implant procedure in people with Breast Cancer, run by University Health Network, Toronto at 4 sites in Canada.
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 2 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BreastQ Quality of Life and Satisfaction Questionnaire (time frame: 12 months post-op). 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 NCT00956384, 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 5 Dec 2024.