Breast CancerPhase 3NCT00639106
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
A Phase 3 study testing Alloderm, Questionnaires and Without ALLODERM, Questionnaires in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Alloderm, Questionnaires and Without ALLODERM, Questionnaires
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Oct 2018
- Phase
- Phase 3
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
- Patients ≥ 21 and ≤ 75 years of age
Who cannot join
- Patient refusal
- Patients who will undergo any of the following:
- Single-stage implant reconstruction
- Combined autogenous tissue expander/implant reconstruction
- Patients with a history of prior irradiation
- Patients with a history of prior surgery with breast implants
Show all 11Show fewer
- Patients with a history of prior axillary lymph node dissection
- Patients who are pregnant
- The following eligibility will be confirmed at the time of surgery.
- Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
- Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27514
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.
Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.
AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
- Conditions
- Breast Cancer
- Being tested
- Alloderm, Questionnaires, Without ALLODERM, Questionnaires
- Keywords
- Breast expander, Breast reconstruction, implants, 08-024
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloderm, QuestionnairesProcedure or surgery
Also called Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)
All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.
Without ALLODERM, QuestionnairesProcedure or surgery
Also called Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)
A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Expander Placement WITH Alloderm Receives: Procedure: Alloderm, Questionnaires |
| B | Active comparator | Expander Placement WITHOUT Alloderm Receives: Procedure: Without ALLODERM, Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.
Measured: conclusion of the study
Secondary outcomes (5)
To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase.
Measured: conclusion of the study
To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use.
Measured: conclusion of the study
To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.
Measured: conclusion of the study
To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.
Measured: conclusion of the study
To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2018
- Study completionOct 2018
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Joseph Disa, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639106
- Sponsor's protocol ID
- 08-024
- Status last verified
- Oct 2018
- First submitted
- 12 Mar 2008
- Last updated
- 3 Oct 2018
- Results posted
- No
Publications
McCarthy CM, Lee CN, Halvorson EG, Riedel E, Pusic AL, Mehrara BJ, Disa JJ. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):57S-66S. doi: 10.1097/PRS.0b013e31825f05b4.
PubMed 23096987
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00639106
- Acronym / sponsor ID
- 08-024
- Conditions
- Breast Cancer
- Keywords
- Breast expander, Breast reconstruction, implants, 08-024
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Michigan, University of North Carolina, Chapel Hill
- Study start
- Mar 2008 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 19 Mar 2008 (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.
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.
Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.
AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Alloderm, QuestionnairesExpander Placement WITH Alloderm |
| B | Active comparator | Procedure: Without ALLODERM, QuestionnairesExpander Placement WITHOUT Alloderm |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
- Patients ≥ 21 and ≤ 75 years of age
Key exclusion criteria (11 listed)
- Patient refusal
- Patients who will undergo any of the following:
- Single-stage implant reconstruction
- Combined autogenous tissue expander/implant reconstruction
- Patients with a history of prior irradiation
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 |
|---|---|---|
| Alloderm, QuestionnairesAlso: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm. | Procedure or surgery | A |
| Without ALLODERM, QuestionnairesAlso: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used. | Procedure or surgery | B |
Primary outcome
whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.
Time frame: conclusion of the study
5 secondary outcomes
To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase.
Time frame: conclusion of the study
To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use.
Time frame: conclusion of the study
To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.
Time frame: conclusion of the study
To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.
Time frame: conclusion of the study
To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction.
Time frame: conclusion of the study
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 Oct 2018.
- Derived from this study: PubMed 23096987McCarthy CM, Lee CN, Halvorson EG, Riedel E, Pusic AL, Mehrara BJ, Disa JJ. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):57S-66S. doi: 10.1097/PRS.0b013e31825f05b4.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Joseph Disa, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alloderm, Questionnaires and Without ALLODERM, Questionnaires in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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 11 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase. (time frame: conclusion of the study). 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 NCT00639106, 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 Oct 2018.