Trial Outcomes & Findings for Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU (NCT NCT01781299)

Last Updated: 2017-05-12

Results Overview

To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

3 years

Results posted on

2017-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	AlloDerm RTU Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU	SurgiMend PRS Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS
Overall Study STARTED	4	5
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AlloDerm RTU Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU	SurgiMend PRS Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	AlloDerm RTU n=4 Participants Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU	SurgiMend PRS n=4 Participants Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS
Complication Rates	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 years following permanent implant placement.

Population: discrepancy is caused by funding ending and no data was collected from SurgiMend arm.

Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.

Outcome measures

Outcome measures
Measure	AlloDerm RTU n=2 Participants Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU	SurgiMend PRS Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS
Aesthetic Evaluation	83.5 units on a scale Interval 83.0 to 84.0	—

Adverse Events

AlloDerm RTU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SurgiMend PRS

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

Kenneth Shestak

University of Pittsburgh Plastic Surgery

Phone: 412-641-1487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	AlloDerm RTU n=4 Participants Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement. AlloDerm RTU	SurgiMend PRS n=5 Participants Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement. SurgiMend PRS	Total n=9 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 8.8 • n=5 Participants	42 years STANDARD_DEVIATION 3.9 • n=7 Participants	48.7 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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 United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants