Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
1 other identifier
interventional
20
1 country
1
Brief Summary
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2016
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 27, 2016
CompletedFirst Posted
Study publicly available on registry
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedResults Posted
Study results publicly available
September 4, 2020
CompletedSeptember 4, 2020
August 1, 2020
3.5 years
February 27, 2016
July 29, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant
The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared
3 months
Secondary Outcomes (1)
Number of Participants Who Required Additional Intervention
3 months
Study Arms (2)
one-port
ACTIVE COMPARATORintervention is placement of one-port tissue expander at time of reconstruction
two-port
ACTIVE COMPARATORintervention is placement of two-port tissue expander at time of reconstruction
Interventions
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Eligibility Criteria
You may qualify if:
- patient agrees to immediate tissue expander breast reconstruction
- a suitable patient for tissue expander reconstruction
You may not qualify if:
- not a surgical candidate for immediate breast reconstruction
- age less than 18
- patient declines tissue expander reconstruction
- patient anticipated to need radiation therapy postoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lesley Wonglead
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lesley Wong
- Organization
- University of Kentucky Division of Plastic Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Lesley Wong, MD
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Plastic Surgery
Study Record Dates
First Submitted
February 27, 2016
First Posted
April 1, 2016
Study Start
February 1, 2016
Primary Completion
July 19, 2019
Study Completion
April 1, 2020
Last Updated
September 4, 2020
Results First Posted
September 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share