Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
TerminatedNAResults postedLast updated 4 December 2019
What this trial tests
NA trial testing Breast Reconstruction, Direct to Implant (DTI) with Strattice™ in Mastectomy and Breast Reconstruction in 131 participants. Terminated before completion.
18 and older, female only, with Mastectomy and Breast Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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.
Unilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1.6
± 1.87
Two Stage Breast Reconstruction
2.2
± 1.91
Bilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1.2
± 1.99
Two Stage Breast Reconstruction
2.3
± 1.10
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)Secondary· 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.
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
15
Two Stage Breast Reconstruction
8
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)Secondary· 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.
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
19
Two Stage Breast Reconstruction
9
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppRSecondary· 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).
Right breast (Grade III)
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
0
Two Stage Breast Reconstruction
0
Right breast (Grade IV)
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
0
Two Stage Breast Reconstruction
0
Left Breast (Grade III)
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1
Two Stage Breast Reconstruction
0
Left Breast (Grade IV)
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
0
Two Stage Breast Reconstruction
0
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISSSecondary· 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.
Unilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1.1
± 1.43
Two Stage Breast Reconstruction
1.4
± 1.40
Bilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1.0
± 1.76
Two Stage Breast Reconstruction
0.9
± 1.28
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed BreastSecondary· 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.
Unilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
2.1
± 2.04
Two Stage Breast Reconstruction
3.0
± 2.60
Bilateral
Group
Value
95% CI
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
1.6
± 2.42
Two Stage Breast Reconstruction
2.8
± 1.29
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first day post-surgery up to 24 months for participants enrolled in the Breast Reconstruction, DTI arm and approximately 25-30 months for participants enrolled in the Two-stage Reconstruction arm..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Breast Reconstruction, Direct to Implant (DTI) With Strattice™
Serious: 49/76 (64%)
Deaths: 0/76
Two Stage Breast Reconstruction
Serious: 27/51 (53%)
Deaths: 0/55
Serious adverse events (74 terms)
Reaction
System
Breast Reconstruction, Dir…
Two Stage Breast Reconstru…
Breast reconstruction
Surgical and medical procedures
—
—
Mastitis
Infections and infestations
—
—
Anisomastia
Reproductive system and breast disorders
—
—
Fat tissue decreased
General disorders
—
—
Postoperative wound complication
Injury, poisoning and procedural complications
—
—
Breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Device extrusion
Product Issues
—
—
Device dislocation
Product Issues
—
—
Skin flap necrosis
Injury, poisoning and procedural complications
—
—
Menorrhagia
Reproductive system and breast disorders
—
—
Capsular contracture associated with breast implant
Reproductive system and breast disorders
—
—
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pyrexia
General disorders
—
—
Impaired healing
General disorders
—
—
Salpingo-oophorectomy
Surgical and medical procedures
—
—
Salpingo-oophorectomy bilateral
Surgical and medical procedures
—
—
Breast operation
Surgical and medical procedures
—
—
Post procedural haemorrhage
Injury, poisoning and procedural complications
—
—
Skin scar contracture
Injury, poisoning and procedural complications
—
—
Wound necrosis
Injury, poisoning and procedural complications
—
—
Wound dehiscence
Injury, poisoning and procedural complications
—
—
Post procedural haematoma
Injury, poisoning and procedural complications
—
—
Skin necrosis
Skin and subcutaneous tissue disorders
—
—
Other adverse events (22 terms — click to expand)
Reaction
System
Breast Reconstruction, Dir…
Two Stage Breast Reconstru…
Seroma
Injury, poisoning and procedural complications
—
—
Post procedural haematoma
Injury, poisoning and procedural complications
—
—
Procedural pain
Injury, poisoning and procedural complications
—
—
Erythema
Skin and subcutaneous tissue disorders
—
—
Breast pain
Reproductive system and breast disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Mastitis
Infections and infestations
—
—
Impaired healing
General disorders
—
—
Hot flush
Vascular disorders
—
—
Wound secretion
Injury, poisoning and procedural complications
—
—
Post procedural swelling
Injury, poisoning and procedural complications
—
—
Capsular contracture associated with breast implant
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LifeCell
Last refreshed: 4 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01910298.