Trial Outcomes & Findings for Immediate Postmastectomy Breast Reconstruction (Strattice Breast) (NCT NCT00619762)

NCT ID: NCT00619762

Last Updated: 2016-11-08

Results Overview

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 %.

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

At the time of expander/implant exchange (Stage II),

Results posted on

2016-11-08

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	17
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LTN - Porcine Acellulare Dermal Matrix in Breast Recon n=17 Participants This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Age, Continuous	49 years STANDARD_DEVIATION 10.6 • n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: At the time of expander/implant exchange (Stage II),

Population: All implanted patients enrolled in the study were included in the analysis

Outcome measures

Outcome measures
Measure	Treatment Arm n=29 Breasts all available patients/breasts who completed specified visit
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Immune Cell Response Percent = Significant	72.4 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Fibroblast Infiltration Percent = None	0 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Fibroblast Infiltration Percent = Few	82.8 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Fibroblast Infiltration Percent = Moderate	17.2 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Fibroblast Infiltration Percent=Significant (dense	0 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Immune Cell Response Percent = None	3.4 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Immune Cell Response Percent = Few	13.7 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Immune Cell Response Percent = Moderate	10.3 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Revascularization Percent = None	65.5 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Revascularization Percent = Few	31 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Revascularization Percent = Moderate	3.4 percentage of breasts
Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix Revascularization Percent = Significant	0 percentage of breasts

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=29 Breasts all available patients/breasts who completed specified visit
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
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
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
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 1.10

Adverse Events

Treatment Arm

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=29 participants at risk；n=17 participants at risk All implanted patients in the study, that is 29 breasts in 17 patients
Respiratory, thoracic and mediastinal disorders pneumothorax	5.9% 1/17 • Number of events 1 • Adverse events were collected from day of implantation through the 12 month visit
Infections and infestations Infection	5.9% 1/17 • Number of events 1 • Adverse events were collected from day of implantation through the 12 month visit
Vascular disorders post operative bleeding	5.9% 1/17 • Number of events 1 • Adverse events were collected from day of implantation through the 12 month visit
Skin and subcutaneous tissue disorders Breast deformity	5.9% 1/17 • Number of events 1 • Adverse events were collected from day of implantation through the 12 month visit

Other adverse events

Other adverse events
Measure	Treatment Arm n=29 participants at risk；n=17 participants at risk All implanted patients in the study, that is 29 breasts in 17 patients
Infections and infestations infection	6.9% 2/29 • Number of events 2 • Adverse events were collected from day of implantation through the 12 month visit

Additional Information

Director of Clinical Operations

LifeCell

Phone: 908.809.7856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place