Breast Reconstruction
Conditions
Brief summary
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
Interventions
DEVICESERI® Surgical Scaffold
Breast reconstruction surgery
Sponsors
Sofregen Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible for enrollment, the subject must: * Be female, greater or equal to 18 years of age * Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant * Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon * Be in good health other than breast pathology and be suited to general anesthesia and planned treatments.
Exclusion criteria
The subject must not: * Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study * Have a known allergy to silk * Have collagen-vascular, connective disease, or bleeding disorders * Have a Body Mass Index (BMI) that is greater than or equal to 35 * Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability * Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer * Have smoked within the last 12 months * Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit * Be pregnant, lactating, or expecting to be within the next 24 months * Have concomitant unrelated condition of breast/chest wall/skin * Have an abscess or infection at the time of surgery * Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation * Have had a prior soft tissue support device implanted in the breast * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months | 6 months | The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | Immediately following Stage I surgery | Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported. |
| Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Stage 2 Surgery, Months 12, 18 and 24 | Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied. |
Countries
United States
Participant flow
Pre-assignment details
Enrollment was defined as having signed the IRB-approved Informed Consent Form. 160 patients were enrolled, of which 139 were implanted with SERI® Surgical Scaffold.
Participants by arm
| Arm | Count |
|---|---|
| Implanted Participants Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Had scaffold removed | 4 |
| Overall Study | Personal reasons | 5 |
| Overall Study | Protocol deviation | 1 |
Baseline characteristics
| Characteristic | Implanted Participants |
|---|---|
| Age, Customized 18 to 19 years | 0 participants |
| Age, Customized 20 to 29 years | 4 participants |
| Age, Customized 30 to 39 years | 15 participants |
| Age, Customized 40 to 49 years | 54 participants |
| Age, Customized 50 to 59 years | 40 participants |
| Age, Customized 60 to 69 years | 22 participants |
| Age, Customized 70+ years | 4 participants |
| Region of Enrollment United States | 139 participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 107 / 139 |
| serious Total, serious adverse events | 25 / 139 |
Outcome results
Primary
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Time frame: 6 months
Population: Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted Participants | Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months | 9.4 units on a scale | Standard Deviation 0.84 |
Secondary
Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery
Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.
Time frame: Immediately following Stage I surgery
Population: Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted Participants | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping after implantation | 0 participants |
| Implanted Participants | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® preparation before implantation | 0 participants |
| Implanted Participants | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® suturing during implantation | 0 participants |
| Implanted Participants | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping before implantation | 0 participants |
| Implanted Participants | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® positioning/drapability during implantation | 0 participants |
| Difficult to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping after implantation | 0 participants |
| Difficult to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® positioning/drapability during implantation | 0 participants |
| Difficult to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping before implantation | 0 participants |
| Difficult to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® suturing during implantation | 0 participants |
| Difficult to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® preparation before implantation | 0 participants |
| Neither Difficult Nor Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® positioning/drapability during implantation | 2 participants |
| Neither Difficult Nor Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® preparation before implantation | 0 participants |
| Neither Difficult Nor Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping before implantation | 0 participants |
| Neither Difficult Nor Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping after implantation | 0 participants |
| Neither Difficult Nor Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® suturing during implantation | 1 participants |
| Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® suturing during implantation | 53 participants |
| Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® preparation before implantation | 15 participants |
| Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping after implantation | 47 participants |
| Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® positioning/drapability during implantation | 61 participants |
| Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping before implantation | 18 participants |
| Very Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® positioning/drapability during implantation | 76 participants |
| Very Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping after implantation | 92 participants |
| Very Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® preparation before implantation | 124 participants |
| Very Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® suturing during implantation | 85 participants |
| Very Easy to Use | Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery | SERI® cutting and shaping before implantation | 121 participants |
Secondary
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points
Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Time frame: Stage 2 Surgery, Months 12, 18 and 24
Population: Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanted Participants | Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Month 12 (n=198 breasts) | 9.5 units on a scale | Standard Deviation 0.89 |
| Implanted Participants | Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Stage 2 Surgery (n=202 breasts) | 9.3 units on a scale | Standard Deviation 1.25 |
| Implanted Participants | Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Month 18 (n=199 breasts) | 9.4 units on a scale | Standard Deviation 1.26 |
| Implanted Participants | Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points | Month 24 (n=195 breasts) | 9.5 units on a scale | Standard Deviation 1.01 |