Breast Cancer
Conditions
Keywords
Breast reconstruction
Brief summary
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.
Detailed description
nothing to add
Interventions
DEVICELTM - a porcine-based surgical mesh
Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy
Sponsors
LifeCell
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy * An ASA Physical Status Classification5 of 1 or 2 (see App I) * Estimated life expectancy \> 1 year
Exclusion criteria
* Clinically significant systemic disease * Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time * Predicted excised breast mass of \>750 gms * Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection * Need for tissue flap in addition to expander * History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction * Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial * Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | At the time of expander/implant exchange (Stage II), | 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 %. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Local Inflammation at and Around the Surgical Site | Postoperative Day 7, 14, 21, 30 days | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | LTN - Porcine Acellulare Dermal Matrix in Breast Recon |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 17 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 | 2 / 29 |
| serious Total, serious adverse events | 3 / 17 |
Outcome results
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 %.
Time frame: At the time of expander/implant exchange (Stage II),
Population: All implanted patients enrolled in the study were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Immune Cell Response Percent = Few | 13.7 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Revascularization Percent = Moderate | 3.4 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Fibroblast Infiltration Percent = None | 0 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Fibroblast Infiltration Percent = Few | 82.8 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Fibroblast Infiltration Percent = Moderate | 17.2 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Fibroblast Infiltration Percent=Significant (dense | 0 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Immune Cell Response Percent = None | 3.4 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Immune Cell Response Percent = Moderate | 10.3 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Immune Cell Response Percent = Significant | 72.4 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Revascularization Percent = None | 65.5 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Revascularization Percent = Few | 31 percentage of breasts |
| Treatment Arm | Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix | Revascularization Percent = Significant | 0 percentage of breasts |
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).
Time frame: Postoperative Day 7, 14, 21, 30 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Severity of Local Inflammation at and Around the Surgical Site | Day 7 (n=28) Final AIR Score | 5.71 units on a scale | Standard Deviation 1.11 |
| Treatment Arm | Severity of Local Inflammation at and Around the Surgical Site | Day 14 (n=27) Final AIR Score | 5.55 units on a scale | Standard Deviation 1.28 |
| Treatment Arm | Severity of Local Inflammation at and Around the Surgical Site | Day 21 (n=27) Final AIR Score | 5.07 units on a scale | Standard Deviation 1.47 |
| Treatment Arm | Severity of Local Inflammation at and Around the Surgical Site | Day 30 (n=25) Final AIR Score | 4.84 units on a scale | Standard Deviation 1.1 |