Trial Outcomes & Findings for Use of Dermal Matrix in Breast Reconstruction (NCT NCT00692692)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

one year from time of operation

Results posted on

2018-03-19

Participant Flow

recruited from the clinic

Participant milestones

Participant milestones
Measure	DermaMatrix experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications	Standard of Care standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Overall Study STARTED	20	16
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Dermal Matrix in Breast Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Both Arms n=36 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: one year from time of operation

Population: study was terminated and 1 year follow up was not done

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 weeks

Number of participants with post surgical infection

Outcome measures

Outcome measures
Measure	DermaMatrix n=20 Participants experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications	Standard of Care n=16 Participants standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Post Surgical Infection	6 Participants	2 Participants

Adverse Events

DermaMatrix

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DermaMatrix n=20 participants at risk experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications	Standard of Care n=16 participants at risk standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Surgical and medical procedures infection	30.0% 6/20 • Number of events 6 • 1 year	12.5% 2/16 • Number of events 2 • 1 year

Additional Information

Jason Wendel, MD

Vanderbilt University Medical Center

Phone: 615-936-0160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place