Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).

Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.

Breast Reconstruction, Direct to Implant (DTI) with Strattice™

Two Stage Breast Reconstruction

Donna Jacobs

The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.

Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.

Single Stage Breast Reconstruction in Female Participants with Mastectomy

Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.

Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out.

Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade \> 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out.

The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast).

Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction.

LifeCell

The number of participants at risk for Serious Adverse Events and Other Adverse Events is based on the Safety Set. 4 participants did not have first surgery date and were not included in Safety Set.

Breast Reconstruction, Direct to Implant (DTI) With Strattice™

Total

Age, Continuous

Sex: Female, Male

Black/African American

Caucasian

Other

Missing

Race/Ethnicity, Customized

Hispanic or Latino

Non-Hispanic or non-Latino

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded.

Therapeutic Area, Head

Unilateral

Bilateral

Post-ISS analysis set consisted of all participants who underwent a mastectomy and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month \[365 days\]-4 week \[28 days\] window). Number analyzed is the number of participants with data available at the given time-point.

Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)

Post-ISS analysis set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month \[365 days\]-4 week \[28 days\] window).

Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)

ppR Follow-up set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed the 24 months ppR visit. Participants whose 24-month visit was performed early due to termination of the study were also included.

Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)

Right breast (Grade III)

Right breast (Grade IV)

Left Breast (Grade III)

Left Breast (Grade IV)

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed for each category includes those participants for whom the Baker grade was assessed.

Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR

The independent reviewer panel was not established and data were not collected due to early termination of the study, hence this endpoint could not be analyzed.

Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel

Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed is the number of participants with data available at the given time-point.

Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS

ppR Follow-up set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed 24 months ppR visit; whose 24-month visit was performed early due to termination of study were also included. Number analyzed is number of participants with data available at given time-point.

Spots Global Cancer Trial Database for breast reconstruction, direct to implant (dti) with strattice™