Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Allergen one-port tissue expander placement
* Device: AlloX2 two-port tissue expander placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one-port<br>intervention is placement of one-port tissue expander at time of reconstruction | Device: Allergen one-port tissue expander placement<br>* patients will be randomized to receive a one port or two port tissue expander for breast reconstruction<br>* Other names: Allergen one-port tissue expander;|
| Active Comparator: two-port<br>intervention is placement of two-port tissue expander at time of reconstruction | Device: AlloX2 two-port tissue expander placement<br>* patients will be randomized to receive a one port or two port tissue expander for breast reconstruction<br>* Other names: AlloX2 two-port tissue expander;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months |