Trial Outcomes & Findings for TiLoop® Bra for Breast Reconstruction (NCT NCT01544023)

Results Overview

Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.

Recruitment status

COMPLETED

Target enrollment

207 participants

Primary outcome timeframe

1 month

Results posted on

2017-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	TiLOOP Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included.
Overall Study STARTED	207
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TiLoop® Bra for Breast Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TiLOOP n=207 Participants Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included.
Age, Continuous	47 years STANDARD_DEVIATION 11.6 • n=93 Participants
Gender Female	207 Participants n=93 Participants
Gender Male	0 Participants n=93 Participants
Region of Enrollment Germany	207 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month

Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.

Outcome measures

Outcome measures
Measure	TiLOOP n=207 Participants Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included.
Participants Who Received TiLOOP Mesh Reconstruction	207 Patients with TiLOOP mesh reconstruction

SECONDARY outcome

Timeframe: 2 years

Secondary study outcome was the prevalence of complications.

Outcome measures

Outcome measures
Measure	TiLOOP n=207 Participants Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP" Bra (pfm medical, Cologne, Germany) were included.
Complication Rate Major Complications	13.4 percentage of participants
Complication Rate Minor Complications	15.6 percentage of participants

Adverse Events

TiLOOP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Max Dieterich

University of Rostock, Klinikum Südstadt der Hansestadt Rostock, Frauenklinik

Phone: +4938144016145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place