Breast CancerNCT02725801
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
A study testing Allergen one-port tissue expander placement and AlloX2 two-port tissue expander placement in people with Breast Cancer, run by Lesley Wong at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Allergen one-port tissue expander placement and AlloX2 two-port tissue expander placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient agrees to immediate tissue expander breast reconstruction
- a suitable patient for tissue expander reconstruction
Who cannot join
- not a surgical candidate for immediate breast reconstruction
- age less than 18
- patient declines tissue expander reconstruction
- patient anticipated to need radiation therapy postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
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.
Read the detailed description
The goal of this study is to compare a traditional single port expander with a two-port expander for equivalency when used for breast reconstruction following mastectomy. Complication rates that will be tracked include seroma, mastectomy skin flap necrosis, infection, wound dehiscence, need for explantation of the expander. Management of seromas will be compared between the two groups. The investigators hypothesize that the AlloX2 expander will be as effective in achieving the final outcome of completion of the second stage of reconstruction with equal or improved complication rates.
Study Design A prospective 1:1 randomized, single center, open label study will compare the traditional 1- port tissue expander with the AlloX2 2-port expander placed during immediate tissue expander breast reconstruction. Due to the nature of the surgery, the study cannot be blinded. Patients will be followed until completion of expansion and exchange for the permanent implant which typically takes 2 to 3 months. Risks factors that have been previously identified to be associated with increased postoperative complications include smoking, obesity, breast size, diabetes, radiation therapy, and expander fill volume will be identified. The final outcome is completion of expansion and exchange to permanent implant.
Standard operative procedure and postoperative care will be done. Both groups will have the same two external drains placed which is standard operative procedure. Complications will be noted at each postoperative clinic visit and entered into a database. Complication rates will be compared between the two groups and associations with risk factors will be analyzed. There will be no cross-over into the other group in case of reconstructive failure. Treatment failures will be treated in the same fashion in the two groups.
- Conditions
- Breast Cancer
- Being tested
- Allergen one-port tissue expander placement, AlloX2 two-port tissue expander placement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen one-port tissue expander placementDevice
Also called Allergen one-port tissue expander
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
AlloX2 two-port tissue expander placementDevice
Also called AlloX2 two-port tissue expander
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| one-port | Active comparator | intervention is placement of one-port tissue expander at time of reconstruction Receives: Device: Allergen one-port tissue expander placement |
| two-port | Active comparator | intervention is placement of two-port tissue expander at time of reconstruction Receives: Device: AlloX2 two-port tissue expander placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Number of Participants Who Required Additional Intervention
Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion19 Jul 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesley Wong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lesley Wong, University of Kentucky
- Investigators
- Lesley Wong, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725801
- Sponsor's protocol ID
- 16-0064
- Status last verified
- Aug 2020
- First submitted
- 27 Feb 2016
- Last updated
- 4 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02725801
- Acronym / sponsor ID
- 16-0064
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lesley WongUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to compare a traditional single port expander with a two-port expander for equivalency when used for breast reconstruction following mastectomy. Complication rates that will be tracked include seroma, mastectomy skin flap necrosis, infection, wound dehiscence, need for explantation of the expander. Management of seromas will be compared between the two groups. The investigators hypothesize that the AlloX2 expander will be as effective in achieving the final outcome of completion of the second stage of reconstruction with equal or improved complication rates.
Study Design A prospective 1:1 randomized, single center, open label study will compare the traditional 1- port tissue expander with the AlloX2 2-port expander placed during immediate tissue expander breast reconstruction. Due to the nature of the surgery, the study cannot be blinded. Patients will be followed until completion of expansion and exchange for the permanent implant which typically takes 2 to 3 months. Risks factors that have been previously identified to be associated with increased postoperative complications include smoking, obesity, breast size, diabetes, radiation therapy, and expander fill volume will be identified. The final outcome is completion of expansion and exchange to permanent implant.
Standard operative procedure and postoperative care will be done. Both groups will have the same two external drains placed which is standard operative procedure. Complications will be noted at each postoperative clinic visit and entered into a database. Complication rates will be compared between the two groups and associations with risk factors will be analyzed. There will be no cross-over into the other group in case of reconstructive failure. Treatment failures will be treated in the same fashion in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-port | Active comparator | Device: Allergen one-port tissue expander placementintervention is placement of one-port tissue expander at time of reconstruction |
| two-port | Active comparator | Device: AlloX2 two-port tissue expander placementintervention is placement of two-port tissue expander at time of reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient agrees to immediate tissue expander breast reconstruction
- a suitable patient for tissue expander reconstruction
Key exclusion criteria (4 listed)
- not a surgical candidate for immediate breast reconstruction
- age less than 18
- patient declines tissue expander reconstruction
- patient anticipated to need radiation therapy postoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen one-port tissue expander placementAlso: Allergen one-port tissue expanderpatients will be randomized to receive a one port or two port tissue expander for breast reconstruction | Device | one-port |
| AlloX2 two-port tissue expander placementAlso: AlloX2 two-port tissue expanderpatients will be randomized to receive a one port or two port tissue expander for breast reconstruction | Device | two-port |
Primary outcome
Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant
Time frame: 3 months
The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared
1 secondary outcome
Number of Participants Who Required Additional Intervention
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Wong, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen one-port tissue expander placement and AlloX2 two-port tissue expander placement in people with Breast Cancer, run by Lesley Wong at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.