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This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTM - a porcine-based surgical mesh | Device | Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %. | At the time of expander/implant exchange (Stage II), |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Local Inflammation at and Around the Surgical Site | The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation). |
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Inclusion Criteria:
Exclusion Criteria:
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women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers
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| Name | Affiliation | Role |
|---|---|---|
| Michael Franz, MD | LifeCell | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | United States | ||||
This study was a prospective, multicenter, open-label study with no control arm. All enrolled women/breasts remained in the study through expander/implant exchange up through the Month 3 post-exchange visit.
17 women were identified & consented to participate in the study. All were enrolled and received study product. Of the 17 women, 5 underwent unilateral reconstruction and 12 underwent bilateral reconstruction for a total of 29 breasts evaluated in the study. Patients were recruited from Hospital settings in PA, IL, Washington DC, NY, and VA.
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| ID | Title | Description |
|---|---|---|
| FG000 | LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct | This was a single arm sudy without a control arm Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | LTN - Porcine Acellulare Dermal Matrix in Breast Recon | This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Severity of Local Inflammation at and Around the Surgical Site | The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation). | Total breasts enrolled were 29. Day 7, N = 28 breasts available Day 14, N = 27 breasts available Day 21, N = 27 breasts available Day 30, N = 25 breasts available | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 7, 14, 21, 30 days | Breasts | Participants |
|
Adverse events were collected from day of implantation through the 12 month visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | All implanted patients in the study, that is 29 breasts in 17 patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment | On POD 7, Mediport was placed. During placement, a pneumothorax occurred. A chest tube was placed to reinflate lung and was removed 5 days later. Event was not considered related to device & resolved without sequelae on POD 12. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment | Infection of breast flap on POD 53 that was possibly related to device and resolved without sequelae Infection of breast flap on POD 37 that ws possibly Resolved to device and resolved without sequelae |
Small number of subjects and breasts analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | LifeCell | 908.809.7856 | djacobs@lifecell.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Tissue sample
| Postoperative Day 7, 14, 21, 30 days |
| Chicago |
| Illinois |
| United States |
| Great Neck | New York | United States |
| Willow Grove | Pennsylvania | United States |
| McLean | Virginia | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
| Primary | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %. | All implanted patients enrolled in the study were included in the analysis | Posted | Number | percentage of breasts | At the time of expander/implant exchange (Stage II), | Breasts | Participants |
|
|
|
| 3 |
| 17 |
| 2 |
| 29 |
|
| Infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment | On POD 21, erythema of lower breast flap was noted & antibiotics initiated. After 2 wk course of antibiotics, erythema had resolved & antibiotics discontinued. Event was considered possibly related to device & resolved without sequelae on POD 36. |
|
| post operative bleeding | Vascular disorders | MedDRA (11.0) | Systematic Assessment | After breast reconstruction, severe bleeding was noted while in recovery rm. Subject returned to OR for control of bleeding by ligation of small artery. Event was not considered to be related to device & resolved without sequelae on day of surgery. |
|
| Breast deformity | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment | On POD 229, subject noted to have significant deformity of breast/lack of subcutaneous tissue.Subject received fat grafting.Event was not considered related to device & subject recovered without sequelae. |
|
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Fibroblast Infiltration Percent=Significant (dense |
|
| Immune Cell Response Percent = None |
|
| Immune Cell Response Percent = Few |
|
| Immune Cell Response Percent = Moderate |
|
| Immune Cell Response Percent = Significant |
|
| Revascularization Percent = None |
|
| Revascularization Percent = Few |
|
| Revascularization Percent = Moderate |
|
| Revascularization Percent = Significant |
|