Trial Outcomes & Findings for Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change (NCT NCT01222390)

Results Overview

The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

1.5 years

Results posted on

2023-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Contour Profile Tissue Exander Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3). Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contour Profile Tissue Exander n=12 Participants Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3). Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
Age, Continuous	57 years STANDARD_DEVIATION 14.2440 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1.5 years

The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).

Outcome measures

Outcome measures
Measure	Contour Profile Tissue Exander n=14 breasts Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3). Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
Breast Projection	19.8205 percentage loss of projection Standard Deviation 13.9231

Adverse Events

Contour Profile Tissue Exander

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Contour Profile Tissue Exander n=12 participants at risk Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3). Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
Reproductive system and breast disorders Delayed wound healing of breast	8.3% 1/12 • Number of events 1 • Adverse event data were collected through 1 year post-operatively. This means 1 year after the tissue expander/implant exchange surgery.

Additional Information

John Y.S. Kim, MD

Northwestern University

Phone: 312-695-0208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place