Soft Tissue Support and Repair
Conditions
Brief summary
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Interventions
DEVICESeriScaffold® Surgical Scaffold
A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
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
* Be female, greater or equal to 18 years of age * Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant * 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
* 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 any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability * 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 With Seri® Surgical Scaffold on an 11-Point Scale | Month 6 | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Month 3, Month 12, Month 18, Month 24 | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. |
| Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Immediately Following Stage 1 Surgery | Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use. |
| Breast Anatomy Measurements | Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24 | Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold. |
| Subject Satisfaction With Breasts on a 5-Point Scale | Baseline, Month 6, Month 12, Month 18, Month 24 | Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied. |
Countries
Germany, Italy, Spain, United Kingdom
Participant flow
Pre-assignment details
Enrollment was defined as having signed the IRB-approved Informed Consent Form. 104 participants were enrolled, of which 100 were implanted with SERI® Surgical Scaffold and are presented in the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| SeriScaffold® Surgical Scaffold Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Had scaffold removed | 15 |
| Overall Study | Personal reasons | 2 |
Baseline characteristics
| Characteristic | SeriScaffold® Surgical Scaffold |
|---|---|
| Age, Continuous | 44.7 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 100 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 | 92 / 100 |
| serious Total, serious adverse events | 53 / 100 |
Outcome results
Primary
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Time frame: Month 6
Population: All participants with a Month 6 visit. 12 subjects exited the study prior to Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | 8.8 Scores on a Scale | Standard Deviation 1.5 |
Secondary
Breast Anatomy Measurements
Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.
Time frame: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24
Population: All implanted breasts evaluated at the designated time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Preoperative | 21.3 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Month 18 | 19.0 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Month 12 | 19.2 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | First Postoperative | 19.0 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Month 24 | 19.0 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Month 3 | 19.0 Centimeters (cm) |
| SeriScaffold® Surgical Scaffold | Breast Anatomy Measurements | Month 6 | 19.2 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Month 18 | 22.9 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Month 6 | 23.0 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Month 3 | 22.7 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Month 12 | 23.0 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Month 24 | 22.9 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | First Postoperative | 22.6 Centimeters (cm) |
| Ease of Use During Surgery = Difficult to Use | Breast Anatomy Measurements | Preoperative | 24.1 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Month 6 | 8.1 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Preoperative | 7.1 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | First Postoperative | 8.1 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Month 3 | 8.1 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Month 12 | 8.0 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Month 18 | 8.0 Centimeters (cm) |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Breast Anatomy Measurements | Month 24 | 8.1 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Month 3 | 14.2 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Month 24 | 13.8 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Month 18 | 13.7 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | First Postoperative | 14.5 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Preoperative | 14.6 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Month 12 | 14.0 Centimeters (cm) |
| Ease of Use During Surgery = Easy to Use | Breast Anatomy Measurements | Month 6 | 14.1 Centimeters (cm) |
Secondary
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.
Time frame: Immediately Following Stage 1 Surgery
Population: All implanted participants. Scaffold cutting and sharping before implantation was reported Not done on n=50
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 0 Participants |
| SeriScaffold® Surgical Scaffold | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 0 Participants |
| SeriScaffold® Surgical Scaffold | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 0 Participants |
| SeriScaffold® Surgical Scaffold | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 0 Participants |
| SeriScaffold® Surgical Scaffold | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 0 Participants |
| Ease of Use During Surgery = Difficult to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 1 Participants |
| Ease of Use During Surgery = Difficult to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 1 Participants |
| Ease of Use During Surgery = Difficult to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 0 Participants |
| Ease of Use During Surgery = Difficult to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 1 Participants |
| Ease of Use During Surgery = Difficult to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 0 Participants |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 5 Participants |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 35 Participants |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 37 Participants |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 37 Participants |
| Ease of Use During Surgery = Neither Difficult Nor Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 3 Participants |
| Ease of Use During Surgery = Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 14 Participants |
| Ease of Use During Surgery = Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 20 Participants |
| Ease of Use During Surgery = Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 6 Participants |
| Ease of Use During Surgery = Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 12 Participants |
| Ease of Use During Surgery = Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 14 Participants |
| Ease of Use During Surgery = Very Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 52 Participants |
| Ease of Use During Surgery = Very Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 77 Participants |
| Ease of Use During Surgery = Very Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 48 Participants |
| Ease of Use During Surgery = Very Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 38 Participants |
| Ease of Use During Surgery = Very Easy to Use | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 49 Participants |
| Not Done | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold preparation before implantation | 0 Participants |
| Not Done | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping after implantation | 0 Participants |
| Not Done | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold cutting and shaping before implantation | 50 Participants |
| Not Done | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold suturing during implantation | 0 Participants |
| Not Done | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Scaffold positioning/drapability during implant | 0 Participants |
Secondary
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Time frame: Month 3, Month 12, Month 18, Month 24
Population: All participants with a visit at the designated time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Month 3 (N=89) | 8.6 Scores on a Scale | Standard Deviation 1.5 |
| SeriScaffold® Surgical Scaffold | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Month 12 (N=83) | 8.8 Scores on a Scale | Standard Deviation 1.3 |
| SeriScaffold® Surgical Scaffold | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Month 18 (N=79) | 8.8 Scores on a Scale | Standard Deviation 1.5 |
| SeriScaffold® Surgical Scaffold | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Month 24 (N=80) | 9.0 Scores on a Scale | Standard Deviation 1.1 |
Secondary
Subject Satisfaction With Breasts on a 5-Point Scale
Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24
Population: All implanted breasts evaluated at the designated time point. Data was not available for 1 subject (both breasts) at baseline, 1 subject (right breast) at Month 6, 2 subjects (right breast) at Month 18 and 1 subject (right breast) at Month 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SeriScaffold® Surgical Scaffold | Subject Satisfaction With Breasts on a 5-Point Scale | Baseline (Missing=0) | 3.7 Scores on a Scale | Standard Deviation 1 |
| SeriScaffold® Surgical Scaffold | Subject Satisfaction With Breasts on a 5-Point Scale | Month 6 (Missing=0) | 4.3 Scores on a Scale | Standard Deviation 0.9 |
| SeriScaffold® Surgical Scaffold | Subject Satisfaction With Breasts on a 5-Point Scale | Month 12 (Missing=1) | 4.4 Scores on a Scale | Standard Deviation 0.8 |
| SeriScaffold® Surgical Scaffold | Subject Satisfaction With Breasts on a 5-Point Scale | Month 18 (Missing=2) | 4.4 Scores on a Scale | Standard Deviation 0.7 |
| SeriScaffold® Surgical Scaffold | Subject Satisfaction With Breasts on a 5-Point Scale | Month 24 (Missing=0) | 4.4 Scores on a Scale | Standard Deviation 0.7 |