Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted Participants | Other | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SERI® Surgical Scaffold | Device | Breast reconstruction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
To be eligible for enrollment, the subject must:
Exclusion Criteria:
The subject must not:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Allergan Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25502862 | Derived | Fine NA, Lehfeldt M, Gross JE, Downey S, Kind GM, Duda G, Kulber D, Horan R, Ippolito J, Jewell M. SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data. Plast Reconstr Surg. 2015 Feb;135(2):339-351. doi: 10.1097/PRS.0000000000000987. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Implanted Participants | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects implanted with SERI® during their Stage I breast reconstruction surgery
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Participants | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
Up to 24 months following SERI implantation
All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at >5% frequency are reported. Individual participants can experience more than 1 AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implanted Participants | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
None to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Immediately following Stage I surgery |
| 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. | Stage 2 Surgery, Months 12, 18 and 24 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery. | Posted | Number | participants | Immediately following Stage I surgery |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Stage 2 Surgery, Months 12, 18 and 24 |
|
|
|
| 25 |
| 139 |
| 107 |
| 139 |
| Device related infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Breast cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lobular breast carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment | This event was classified as unrelated to the SERI® surgical scaffold but related to the surgical procedure. The subject was treated with antihistamines and anticoagulants. The event was reported as serious and ongoing |
|
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal ulceration | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment | This event was classified as unrelated to the SERI® surgical scaffold or the procedure and resolved without sequelae after treatment with antipruritics and antibiotics |
|
| Parotitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Metastases to spleen | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment | This event was classified as unrelated to the SERI® surgical scaffold or the procedure. This event remains ongoing. |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pericarditis constrictive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Capsular contracture associated with breast implant | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Implant site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Breast complication associated with device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Capsular contracture associated with breast implant | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.
| SERI® cutting and shaping before implantation |
|
| SERI® positioning/drapability during implantation |
|
| SERI® cutting and shaping after implantation |
|
| SERI® suturing during implantation |
|
|
| Month 24 (n=195 breasts) |
|