Trial Outcomes & Findings for Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction (NCT NCT02725801)

NCT ID: NCT02725801

Last Updated: 2020-09-04

Results Overview

The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-09-04

Participant Flow

Participant milestones

Measure	One-port intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Two-port intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Overall Study STARTED	8	12
Overall Study COMPLETED	8	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	One-port n=8 Participants intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Two-port n=12 Participants intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants	9 Participants n=12 Participants	17 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	3 Participants n=12 Participants	3 Participants n=20 Participants
Age, Continuous	46.75 years STANDARD_DEVIATION 12.28 • n=8 Participants	51.08 years STANDARD_DEVIATION 13.83 • n=12 Participants	48.92 years STANDARD_DEVIATION 3.06 • n=20 Participants
Sex: Female, Male Female	8 Participants n=8 Participants	12 Participants n=12 Participants	20 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=12 Participants	0 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	8 participants n=8 Participants	12 participants n=12 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months

The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared

Outcome measures

Measure	One-port n=8 Participants intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Two-port n=12 Participants intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant	8 Participants	12 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study

Outcome measures

Measure	One-port n=8 Participants intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Two-port n=12 Participants intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Number of Participants Who Required Additional Intervention	1 Participants	4 Participants

Adverse Events

One-port

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Two-port

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	One-port n=8 participants at risk intervention is placement of one-port tissue expander at time of reconstruction Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction	Two-port n=12 participants at risk intervention is placement of two-port tissue expander at time of reconstruction AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Surgical and medical procedures re-operation	12.5% 1/8 • Number of events 1 • 3 months All-cause mortality was not monitored/assessed.	33.3% 4/12 • Number of events 4 • 3 months All-cause mortality was not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Lesley Wong

University of Kentucky Division of Plastic Surgery

Phone: 859-323-7505

Email: lesley.wong@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place