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

Not Applicable

Terminated

Conditions: Mastectomy and Breast Reconstruction

Interventions: Procedure: Two Stage Breast Reconstruction
Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™

Registration Number: NCT01910298

Lead Sponsor: LifeCell

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 131

Inclusion Criteria

Female 18 years or older
A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
Estimated life expectancy > 3 years
Able and willing to return for all scheduled and required study visits
Able to provide written informed consent for study participation

Exclusion Criteria

Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
Previous radiation therapy to either breast at any time
Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment
Body mass index (BMI) <17 or > 30
Co-morbid factors which predispose to postoperative infection, e.g. diabetes, collagen vascular disease, chronic steroid (except inhalers)/immunosuppressant use, immune deficiency, or co-existent infection
Pregnant or lactating
3rd degree ptosis
Prior breast surgery including breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope
Prior use of a device (mesh or matrix) in the Breast
Concomitant unrelated condition of breast/chest wall/skin that, as determined by the investigator, could adversely affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
Planned autologous tissue flap in addition to prosthetic implant
Use of permanent expander implants such as Becker expanders or the Natrelle™ Permanent expander 150
Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
Currently enrolled or plans to enroll in another clinical trial unless it is: a registry, a retrospective study, a neo-adjuvant chemotherapy trial (as long as the chemotherapy regimen has been stopped 4 weeks prior to mastectomy), or a hormone/anti-hormonal therapy trial
Any of the conditions identified within the labelled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two Stage Breast Reconstruction	Two Stage Breast Reconstruction	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™	Breast Reconstruction, Direct to Implant (DTI) with Strattice™	Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).

Primary Outcome Measures

Name	Time	Method
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)	Up to 12 months post ISS	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)	Up to 12 months post ISS	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.
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS	Baseline up to 6 months post ISS	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.
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast	Within 24 months ppR	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.
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)	Up to 24 months ppR	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.
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR	Up to 24 months ppR	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).
Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel	Baseline up to Month 24

Trial Locations

Locations (18): Kliniken Essen-Mitte
🇩🇪
Essen, Germany
Wythenshawe Hospital UHSM NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
Institut Bergonie
🇫🇷
Bordeaux, France
Hopital Tenon APHP
🇫🇷
Paris, France
Centre Oscar Lambret
🇫🇷
Lille Cedex, France
Institut du Cancer de Montpellier Val d'Aurelle
🇫🇷
Montpellier Cedex 5, France
L'Institut du Sein- Paris Breast Center
🇫🇷
Paris, France
Universitätsklinikum Erlangen
🇩🇪
Erlangen, Germany
Medizinische Hochschule Hannover
🇩🇪
Hannover, Germany
Universitäts-Frauenklinik Heidelberg
🇩🇪
Heidelberg, Germany
Klinik der Universität München, Campus Innenstadt
🇩🇪
Munich, Germany
Universitätsklinikum Freiburg
🇩🇪
Freiburg, Germany
Klinikum rechts der Isar
🇩🇪
Munich, Germany
Asklepios Paulinen Klinik
🇩🇪
Wiesbaden, Germany
Frimley Park Hospital
🇬🇧
Frimley, United Kingdom
Dorset County Hospital
🇬🇧
Dorchester, United Kingdom
St Luke's hospital / Bradford Royal Infirmary (BRI)
🇬🇧
Bradford, United Kingdom
City Hospital
🇬🇧
Nottingham, United Kingdom