Breast CancerNCT03494244
Evaluation of ADM Soft Tissue Reinforcement
An observational study of Breast Cancer and Surgery, run by Massachusetts General Hospital.
Trial summary
The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Surgery, Surgical Item, Retained
- What is being tested?
- Direct-to-implant breast reconstruction and Acellular dermal matrix
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who undergo breast reconstruction if they have mastectomies for the purpose of either removing breast cancer or prophylactic removal of the breasts following diagnosis of genetic predisposition for breast cancer based on family history or genetic testing
Who may be able to join
- direct to implant breast reconstruction
Who cannot join
- BMI > 30
- history of smoking within 1 year of enrollment
- previous breast surgery
- malnutrition or cachexia
- breast implant volume ≤ 125 mL or ≥ 700 mL
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-operative Outcomes as Clinical Evidence for Soft Tissue Reinforcement: a Prospective Cohort Study.
The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.
Read the detailed description
This study will measure objective clinical endpoints in DTI breast reconstruction. A total of 152 patients (76 for both ADM and non-ADM cohorts) will be followed in a prospectively recorded database. The clinical care of the patient will be safe-guarded to proceed entirely unaffected by the study. Enrollment will be limited to patients of Dr. Liao and Dr. William Austen at the Massachusetts General Hospital who are scheduled to undergo immediate, DTI breast reconstruction. Patients may undergo immediate, DTI breast reconstruction if they have mastectomies for the purpose of either removing breast cancer or prophylactic removal of the breasts following diagnosis of genetic predisposition for breast cancer based on family history or genetic testing. All patients will be women. The age minimum is 18 years. There is no age maximum.
The study will involve only recording of data (patient characteristics, clinical data, reconstructive parameters (size of ADM and implant used), drain placement, number and caliber of drains, outcomes of surgery). At initial consultation, per the standard routine for Dr. Liao's patients, digital photographs and 3D photographs will be obtained below the neck, eliminating any patient identifiers. Patients will be followed per routine care protocol. A typical patient will be followed weekly for 6 weeks, then at 3 months, 6 months, and 12 months. All photographs are de-identified and taken below the neck, and are kept in a secure photograph database maintained by the Division of Plastic and Reconstructive Surgery. The clinical care of the patient adheres strictly to the existing standard of care by the surgeon (Dr. Liao). The study will involve only the recording of data without any additional interaction with the patient.
The primary clinical endpoint to be measured is breast form. Secondary clinical endpoints include: seroma, infection, skin necrosis, wound problems, explantation, and any other minor or major complications. Breast thickness and landmark positioning will be recorded as quantitative measures of breast form. The investigators will determine tissue thickness in the following areas: (a) point of maximal projection, (b) inferior pole of the breast, and (c) the midpoint between the aforementioned areas, a and b. Measurements will be made using transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). Landmark mapping will be conducted via Vectra imaging software. The positioning of the nipples and inframammary fold (IMF) relative to the sternal notch will be determined through a predetermined Vectra algorithm. Post-operative imaging will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Digital images will provide objective information on aesthetic outcomes and evidence of ptosis, pseudoptosis, symmetry, chest position, or nipple position (if nipple sparing) for both cohorts.
In addition to objective clinical outcomes, patient reported outcomes (PRO) will be measured with the Breast-Q questionnaire. The survey will be administered during the initial consult (pre-mastectomy module) and then reassessed (post-mastectomy module) at 3 months (early recovery) and 12 months (late recovery) to track changes in quality of life (QOL). The PRO will be compared between the ADM and non-ADM cohorts.
The investigators expect to reach the goal of 152 patients within 6 to 12 months, and complete the study with a minimum of 6 months of follow-up within 24 months.
- Conditions
- Breast Cancer, Surgery, Surgical Item, Retained
- Being tested
- Direct-to-implant breast reconstruction, Acellular dermal matrix
- Keywords
- acellular dermal matrix, breast reconstruction, efficacy
- Medical subject headings
- Breast Neoplasms, Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-to-implant breast reconstructionProcedure or surgery
Also called DTI
Terminal prosthetic implanted at the time of mastectomy.
Acellular dermal matrixDevice
Also called ADM
Banked tissue used to support the directly implanted breast prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| ADM | Patients having undergone direct-to-implant breast reconstruction using acellular dermal matrix. Receives: Procedure: Direct-to-implant breast reconstruction; Device: Acellular dermal matrix | |
| Non-ADM (Vicryl) | Patients having undergone direct-to-implant breast reconstruction using non-acellular dermal matrix mesh (Vicryl mesh). Receives: Procedure: Direct-to-implant breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tissue thickness (measured in millimeters).
Anatomic measurement of mastectomy skin flap thickness will be conducted comparing ADM and Vicryl patient cohorts. Breast skin flap thickness will be measured at landmarks reproducible over time and comparable between patients. We will determine tissue thickness in the following areas: (a) point of maximal projection, (b) the midpoint between maximal projection and the inferior pole of the breast, and (c) the inferior pole of the breast. During measurement, patients will be positioned upright, such that gravitational force will be exerted on the breast skin flap by the prosthesis. Tissue thickness will be determined via transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). The mastectomy skin flap will be defined as the tissue between the air-skin interface to the deep margin of the subcutaneous layer. Tissue thickness, in millimeters (mm), will be calculated using a predetermined prediction algorithm.
Measured: Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Change in Anatomic landmark position (measured in centimeters)
Thoracoabdominal images will be captured using Vectra 3M, a three-dimensional imaging (TDI) system commonly used to evaluate anatomical parameters of breast form and volume. This study uniquely employs TDI to evaluate the position of breast landmarks over time to objectively assess ptosis following ADM and non- ADM-based breast reconstructions. The following breast landmarks will be identified using a Vectra algorithm and confirmed by a trained medical assistant: sternal notch (Sn), nipple (N), and inframammary fold (IMF). Breast ptosis, defined as depression of breast tissue with respect to the IMF, will be objectively assessed as the relative position of nipple to the inferior margin. Changes in Sn-IMF and N-IMF lengths will be normalized across implant size. This will provide an indication of the amount of breast ptosis experienced by ADM and non-ADM cohorts per unit volume of prosthesis.
Measured: Post-surgical, follow-up intervals extending to one year following reconstruction. These cardinal landmarks of breast form and axis length will be collected at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Secondary outcomes (2)
Infection
Surgical site infection as defined by criteria described by centers for disease control and prevention (CDC).
Measured: 90 days post-operatively.
Self reported outcomes
Patient subjective evaluation of aesthetic outcome via Breast-Q questionnaire.
Measured: Post-surgical, follow-up intervals extending to one year following reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chienwei Eric Liao, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494244
- Sponsor's protocol ID
- 2018P000084
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No intention to share individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Outcomes as Clinical Evidence for Soft Tissue Reinforcement: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03494244
- Acronym / sponsor ID
- 2018P000084
- Conditions
- Breast Cancer, Surgery, Surgical Item, Retained
- Keywords
- acellular dermal matrix, breast reconstruction, efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 11 Apr 2018 (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 use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.
Detailed description
This study will measure objective clinical endpoints in DTI breast reconstruction. A total of 152 patients (76 for both ADM and non-ADM cohorts) will be followed in a prospectively recorded database. The clinical care of the patient will be safe-guarded to proceed entirely unaffected by the study. Enrollment will be limited to patients of Dr. Liao and Dr. William Austen at the Massachusetts General Hospital who are scheduled to undergo immediate, DTI breast reconstruction. Patients may undergo immediate, DTI breast reconstruction if they have mastectomies for the purpose of either removing breast cancer or prophylactic removal of the breasts following diagnosis of genetic predisposition for breast cancer based on family history or genetic testing. All patients will be women. The age minimum is 18 years. There is no age maximum.
The study will involve only recording of data (patient characteristics, clinical data, reconstructive parameters (size of ADM and implant used), drain placement, number and caliber of drains, outcomes of surgery). At initial consultation, per the standard routine for Dr. Liao's patients, digital photographs and 3D photographs will be obtained below the neck, eliminating any patient identifiers. Patients will be followed per routine care protocol. A typical patient will be followed weekly for 6 weeks, then at 3 months, 6 months, and 12 months. All photographs are de-identified and taken below the neck, and are kept in a secure photograph database maintained by the Division of Plastic and Reconstructive Surgery. The clinical care of the patient adheres strictly to the existing standard of care by the surgeon (Dr. Liao). The study will involve only the recording of data without any additional interaction with the patient.
The primary clinical endpoint to be measured is breast form. Secondary clinical endpoints include: seroma, infection, skin necrosis, wound problems, explantation, and any other minor or major complications. Breast thickness and landmark positioning will be recorded as quantitative measures of breast form. The investigators will determine tissue thickness in the following areas: (a) point of maximal projection, (b) inferior pole of the breast, and (c) the midpoint between the aforementioned areas, a and b. Measurements will be made using transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). Landmark mapping will be conducted via Vectra imaging software. The positioning of the nipples and inframammary fold (IMF) relative to the sternal notch will be determined through a predetermined Vectra algorithm. Post-operative imaging will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Digital images will provide objective information on aesthetic outcomes and evidence of ptosis, pseudoptosis, symmetry, chest position, or nipple position (if nipple sparing) for both cohorts.
In addition to objective clinical outcomes, patient reported outcomes (PRO) will be measured with the Breast-Q questionnaire. The survey will be administered during the initial consult (pre-mastectomy module) and then reassessed (post-mastectomy module) at 3 months (early recovery) and 12 months (late recovery) to track changes in quality of life (QOL). The PRO will be compared between the ADM and non-ADM cohorts.
The investigators expect to reach the goal of 152 patients within 6 to 12 months, and complete the study with a minimum of 6 months of follow-up within 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM | – | Procedure: Direct-to-implant breast reconstruction, Device: Acellular dermal matrixPatients having undergone direct-to-implant breast reconstruction using acellular dermal matrix. |
| Non-ADM (Vicryl) | – | Procedure: Direct-to-implant breast reconstructionPatients having undergone direct-to-implant breast reconstruction using non-acellular dermal matrix mesh (Vicryl mesh). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergo breast reconstruction if they have mastectomies for the purpose of either removing breast cancer or prophylactic removal of the breasts following diagnosis of genetic predisposition for breast cancer based on family history or genetic testing
Key inclusion criteria (1 listed)
- direct to implant breast reconstruction
Key exclusion criteria (5 listed)
- BMI > 30
- history of smoking within 1 year of enrollment
- previous breast surgery
- malnutrition or cachexia
- breast implant volume ≤ 125 mL or ≥ 700 mL
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 |
|---|---|---|
| Direct-to-implant breast reconstructionAlso: DTITerminal prosthetic implanted at the time of mastectomy. | Procedure or surgery | ADM, Non-ADM (Vicryl) |
| Acellular dermal matrixAlso: ADMBanked tissue used to support the directly implanted breast prosthesis. | Device | ADM |
Primary outcome
Change in Tissue thickness (measured in millimeters).
Time frame: Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Anatomic measurement of mastectomy skin flap thickness will be conducted comparing ADM and Vicryl patient cohorts. Breast skin flap thickness will be measured at landmarks reproducible over time and comparable between patients. We will determine tissue thickness in the following areas: (a) point of maximal projection, (b) the midpoint between maximal projection and the inferior pole of the breast, and (c) the inferior pole of the breast. During measurement, patients will be positioned upright, such that gravitational force will be exerted on the breast skin flap by the prosthesis. Tissue thickness will be determined via transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). The mastectomy skin flap will be defined as the tissue between the air-skin interface to the deep margin of the subcutaneous layer. Tissue thickness, in millimeters (mm), will be calculated using a predetermined prediction algorithm.
Change in Anatomic landmark position (measured in centimeters)
Time frame: Post-surgical, follow-up intervals extending to one year following reconstruction. These cardinal landmarks of breast form and axis length will be collected at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.
Thoracoabdominal images will be captured using Vectra 3M, a three-dimensional imaging (TDI) system commonly used to evaluate anatomical parameters of breast form and volume. This study uniquely employs TDI to evaluate the position of breast landmarks over time to objectively assess ptosis following ADM and non- ADM-based breast reconstructions. The following breast landmarks will be identified using a Vectra algorithm and confirmed by a trained medical assistant: sternal notch (Sn), nipple (N), and inframammary fold (IMF). Breast ptosis, defined as depression of breast tissue with respect to the IMF, will be objectively assessed as the relative position of nipple to the inferior margin. Changes in Sn-IMF and N-IMF lengths will be normalized across implant size. This will provide an indication of the amount of breast ptosis experienced by ADM and non-ADM cohorts per unit volume of prosthesis.
2 secondary outcomes
Infection
Time frame: 90 days post-operatively.
Self reported outcomes
Time frame: Post-surgical, follow-up intervals extending to one year following reconstruction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No. No intention to share individual participant data to other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Massachusetts General 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Liao, MD, PhD (6176435975, cliao@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tissue thickness (measured in millimeters). (time frame: Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 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?
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 12 Mar 2019.