Patients With Breast Cancer Requiring Mastectomy and Suitable for ReconstructionNCT01853436
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
A study testing Strattice™ Reconstructive Tissue Matrix in people with Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction, run by LifeCell at 1 site in Italy.
Trial summary
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
- What is being tested?
- Strattice™ Reconstructive Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jul 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A study patient may be included if she:
- Has planned to undergo a unilateral or bilateral mastectomy and have small to medium size breasts (predicted breast implant size maximally 500 gms), with none or moderate (Grade 1 or 2) ptosis, and healthy, sufficiently thick, well-vascularized skin flaps anticipated by the surgeon.
- Is a clinically suitable candidate for immediate reconstruction with ADM based single stage reconstruction technique (as defined for use in the Experimental arm).
- Is female, ≥18 years of age.
- Is willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant by either the Experimental (ADM based single stage) or the Control (TE/Implant based two stage) techniques.
- Is in good health other than breast pathology and is suited to general anesthesia and planned treatments.
- Understands and is willing to follow all aspects of the study protocol including randomization and has signed and dated the approved Informed Consent Form prior to any study-related procedures being performed.
Who cannot join
- A study patient is excluded from participation to the study if she:
- Has undergone breast radiation treatment and/or be preoperatively evaluated to require radiation treatment to the breast area during the course of the study.
- Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
- Has a BMI that is ≥ 35.
- Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
- Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer.
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- Currently has an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit.
- Is pregnant, or lactating.
- Has concomitant unrelated condition of breast/chest wall/skin that, as determined by the PI, could affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum).
- Has an abscess or infection at the time of surgery.
- Has undergone previous breast surgery with the exception of breast biopsy, cyst removal, and lumpectomy.
- Has had a prior soft tissue support device implanted in the breast or is participating in another clinical trial with a breast related device (e.g. drains, expanders, implants).
- Has a known pork allergy or is sensitive to polysorbate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room.
Read the detailed description
This study is designed to compare the clinical outcomes of patients undergoing mastectomy followed by a direct to implant breast reconstruction with Strattice™ Reconstructive Tissue Matrix to patients undergoing a standard two-stage reconstruction without Strattice™ or any other mesh or tissue flap.
Potential candidates for the study will be identified through routine practice. Women who meet the inclusion and exclusion criteria will be invited to participate in the study. A screening visit will take place maximally 30 days prior to surgery.
Randomization will occur maximally 7 days prior to the mastectomy procedure. As some women may have to undergo bilateral mastectomy and reconstruction, the randomization scheme will ensure that both breasts will be reconstructed with the same surgical approach.
The Day of Surgery consists of both a mastectomy and a breast reconstruction. The surgical site and the breasts will be evaluated on the day of hospital discharge and at postoperative days 14 and 30 for all patients after each hospital admission. During these visits, the breasts will be examined and an Acute Inflammatory Assessment (AIR) will be completed. In addition the breast flaps and incisions will be evaluated for signs of infection, seroma, hematoma or skin necrosis.
- Being tested
- Strattice™ Reconstructive Tissue Matrix
- Keywords
- Breast Cancer, Reconstructive Tissue Matrix, Acellular Dermal Matrices (ADM)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice™ Reconstructive Tissue MatrixDevice
Experimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique.
| Study group | Role | What they receive |
|---|---|---|
| Single stage reconstructions | Experimental | as defined for use in the Experimental arm Receives: Device: Strattice™ Reconstructive Tissue Matrix |
| Two stage breast reconstructions | Other | CONTROL: standard two stage breast reconstructions without Acellular dermal matrices (ADM), in patients who are clinically suitable candidates for reconstruction with Acellular dermal matrices(ADM)based single stage reconstruction technique. Reconstructions with Strattice™ Reconstructive Tissue Matrix Receives: Device: Strattice™ Reconstructive Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgeries where a differentiation will be made between major and minor depending upon the requirement to enter the breast pocket under general anesthesia.
Total numbers of major and of minor surgeries for each patient during the full trial period and including any surgeries that the PI determines are clinically still necessary at the end of the trial period. Major procedures are defined as those involving the patient to be treated in the OR: re-entering the implant pocket; soft-tissue flaps not performed under local anesthesia; general anesthesia; or procedures requiring inpatient admission. Other procedures, including for instance CT-guided percutaneous drainage or breast fat grafting (lipofilling), are defined as minor procedures.
Measured: At month 36 post-implant placement
Secondary outcomes (2)
Post operative sensation at Postoperative
Patients' subjective experience of sensation in the reconstructed breast as estimated by the subjective scale. In the experimental arm, this datum will be assessed at the POD 14 visit after the single stage implant (SSI) + ADM procedure; in the control arm\ this datum will be assessed at the POD 14 visit after the first stage and again POD 14 after the second surgical stage (TE/Implant exchange). The questionnaire will also be completed at Months 6, 12, 24 and 36.
Measured: At Post-op Days 14, 30 and at Months 6, 12, 24, and 36 post implant placement
Quality of life pre-operatively and at post operative
Patients' QoL, including emotional and satisfaction status, will be assessed before the reconstruction procedure and at POD 30 after single stage implant (SSI) + ADM in the experimental group via the Short Form (SF)-36 questionnaire; and at POD 30 after TE/Implant exchange in the control group.
Measured: At month 6,12,24, and 36 post-implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2017
- Study completionJul 2017 (estimated)
Why it stopped: Lifecell became part of Allergan; company deciscion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Breast Cancer Requiring Mastectomy and Suitable for ReconstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Spano, MD, Principal investigator, Fondazione IRCCS Instituto Nazionale dei Tumori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853436
- Sponsor's protocol ID
- LFC 2012.04.01
- Status last verified
- May 2017
- First submitted
- 7 May 2013
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants
- ClinicalTrials.gov ID
- NCT01853436
- Acronym / sponsor ID
- LFC 2012.04.01
- Keywords
- Breast Cancer, Reconstructive Tissue Matrix, Acellular Dermal Matrices (ADM)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lifecell became part of Allergan; company deciscion
- Enrolment
- 36 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 May 2013 (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.
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room.
Detailed description
This study is designed to compare the clinical outcomes of patients undergoing mastectomy followed by a direct to implant breast reconstruction with Strattice™ Reconstructive Tissue Matrix to patients undergoing a standard two-stage reconstruction without Strattice™ or any other mesh or tissue flap.
Potential candidates for the study will be identified through routine practice. Women who meet the inclusion and exclusion criteria will be invited to participate in the study. A screening visit will take place maximally 30 days prior to surgery.
Randomization will occur maximally 7 days prior to the mastectomy procedure. As some women may have to undergo bilateral mastectomy and reconstruction, the randomization scheme will ensure that both breasts will be reconstructed with the same surgical approach.
The Day of Surgery consists of both a mastectomy and a breast reconstruction. The surgical site and the breasts will be evaluated on the day of hospital discharge and at postoperative days 14 and 30 for all patients after each hospital admission. During these visits, the breasts will be examined and an Acute Inflammatory Assessment (AIR) will be completed. In addition the breast flaps and incisions will be evaluated for signs of infection, seroma, hematoma or skin necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single stage reconstructions | Experimental | Device: Strattice™ Reconstructive Tissue Matrixas defined for use in the Experimental arm |
| Two stage breast reconstructions | Other | Device: Strattice™ Reconstructive Tissue MatrixCONTROL: standard two stage breast reconstructions without Acellular dermal matrices (ADM), in patients who are clinically suitable candidates for reconstruction with Acellular dermal matrices(ADM)based single stage reconstruction technique. Reconstructions with Strattice™ Reconstructive Tissue Matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has planned to undergo a unilateral or bilateral mastectomy and have small to medium size breasts (predicted breast implant size maximally 500 gms), with none or moderate (Grade 1 or 2) ptosis, and healthy, sufficiently thick, well-vascularized skin flaps anticipated by the surgeon.
- Is a clinically suitable candidate for immediate reconstruction with ADM based single stage reconstruction technique (as defined for use in the Experimental arm).
- Is female, ≥18 years of age.
- Is willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant by either the Experimental (ADM based single stage) or the Control (TE/Implant based two stage) techniques.
- Is in good health other than breast pathology and is suited to general anesthesia and planned treatments.
Key exclusion criteria (13 listed)
- Has undergone breast radiation treatment and/or be preoperatively evaluated to require radiation treatment to the breast area during the course of the study.
- Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
- Has a BMI that is ≥ 35.
- Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
- Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer.
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 |
|---|---|---|
| Strattice™ Reconstructive Tissue MatrixExperimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique. | Device | Single stage reconstructions, Two stage breast reconstructions |
Primary outcome
Number of surgeries where a differentiation will be made between major and minor depending upon the requirement to enter the breast pocket under general anesthesia.
Time frame: At month 36 post-implant placement
Total numbers of major and of minor surgeries for each patient during the full trial period and including any surgeries that the PI determines are clinically still necessary at the end of the trial period. Major procedures are defined as those involving the patient to be treated in the OR: re-entering the implant pocket; soft-tissue flaps not performed under local anesthesia; general anesthesia; or procedures requiring inpatient admission. Other procedures, including for instance CT-guided percutaneous drainage or breast fat grafting (lipofilling), are defined as minor procedures.
2 secondary outcomes
Post operative sensation at Postoperative
Time frame: At Post-op Days 14, 30 and at Months 6, 12, 24, and 36 post implant placement
Quality of life pre-operatively and at post operative
Time frame: At month 6,12,24, and 36 post-implant placement
Results and safety
The study was stopped early (reason given: Lifecell became part of Allergan; company deciscion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
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.
Andrea Spano, MD principal investigator
Fondazione IRCCS Instituto Nazionale dei Tumori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strattice™ Reconstructive Tissue Matrix in people with Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction, run by LifeCell at 1 site in Italy.
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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 May 2017. 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 Italy. 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 was stopped early (reason given: Lifecell became part of Allergan; company deciscion). Results are not available in the source record.
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 surgeries where a differentiation will be made between major and minor depending upon the requirement to enter the breast pocket under general anesthesia. (time frame: At month 36 post-implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2017.