Breast Cancer
Conditions
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.
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.
Interventions
DEVICEAllergen one-port tissue expander placement
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
DEVICEAlloX2 two-port tissue expander placement
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Sponsors
Lesley Wong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patient agrees to immediate tissue expander breast reconstruction * a suitable patient for tissue expander reconstruction
Exclusion criteria
* not a surgical candidate for immediate breast reconstruction * age less than 18 * patient declines tissue expander reconstruction * patient anticipated to need radiation therapy postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | 3 months | The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required Additional Intervention | 3 months | Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 12 |
| Total | 20 |
Baseline characteristics
| Characteristic | Two-port | Total | One-port |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 17 Participants | 8 Participants |
| Age, Continuous | 51.08 years STANDARD_DEVIATION 13.83 | 48.92 years STANDARD_DEVIATION 3.06 | 46.75 years STANDARD_DEVIATION 12.28 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 20 participants | 8 participants |
| Sex: Female, Male Female | 12 Participants | 20 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 8 | 0 / 12 |
| serious Total, serious adverse events | 1 / 8 | 4 / 12 |
Outcome results
Primary
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One-port | Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | 8 Participants |
| Two-port | Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | 12 Participants |
Secondary
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One-port | Number of Participants Who Required Additional Intervention | 1 Participants |
| Two-port | Number of Participants Who Required Additional Intervention | 4 Participants |