Trial Outcomes & Findings for One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure (NCT NCT00956384)

Last Updated: 2024-12-05

Results Overview

Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

198 participants

Primary outcome timeframe

12 months post-op

Results posted on

2024-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	One-stage Dermal Matrix/Implant One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant
Overall Study STARTED	102	96
Overall Study COMPLETED	86	78
Overall Study NOT COMPLETED	16	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One-stage Dermal Matrix/Implant n=86 Participants One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant n=78 Participants Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	78 Participants n=7 Participants	164 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.9 Years STANDARD_DEVIATION 8.4 • n=5 Participants	46 Years STANDARD_DEVIATION 11.2 • n=7 Participants	45.5 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	78 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	65 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	86 participants n=5 Participants	78 participants n=7 Participants	164 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-op

Outcome measures

Outcome measures
Measure	One-stage Dermal Matrix/Implant n=86 Participants One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant n=78 Participants Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant
BreastQ Quality of Life and Satisfaction Questionnaire	65.32 score on a scale Standard Deviation 13.63	67.07 score on a scale Standard Deviation 16.05

SECONDARY outcome

Timeframe: 6- months post-op

Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery

Outcome measures

Outcome measures
Measure	One-stage Dermal Matrix/Implant n=86 Participants One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant n=78 Participants Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant
Number of Participants With Short Term Surgical Complications	32 Participants	27 Participants

SECONDARY outcome

Timeframe: 12 months post-op

Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit

Outcome measures

Outcome measures
Measure	One-stage Dermal Matrix/Implant n=86 Participants One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant n=78 Participants Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant
Number of Participants With Long Term Surgical Complications	23 Participants	12 Participants

Adverse Events

One-stage Dermal Matrix/Implant

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Two-stage Tissue Expander/Implant

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	One-stage Dermal Matrix/Implant n=86 participants at risk One-stage breast reconstruction with dermal matrix and implant One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant	Two-stage Tissue Expander/Implant n=78 participants at risk Two-stage breast reconstruction with tissue expander and implant Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant
Surgical and medical procedures Implant or TE exposure	8.1% 7/86 • Number of events 7 • 2 years Chart reviewed on a regular schedule.	7.7% 6/78 • Number of events 6 • 2 years Chart reviewed on a regular schedule.

Additional Information

Dr. Toni Zhong

University Health Network

Phone: 4163404800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place