An interventional study of Allergen one-port tissue expander placement and AlloX2 two-port tissue expander placement in Breast Cancer, sponsored by Lesley Wong. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Lesley Wong · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Lesley Wong as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intervention is placement of one-port tissue expander at time of reconstruction
Device: Allergen one-port tissue expander placement
intervention is placement of two-port tissue expander at time of reconstruction
Device: AlloX2 two-port tissue expander placement
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Also known as: Allergen one-port tissue expander
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
Also known as: AlloX2 two-port tissue expander
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
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
| Milestone | One-port | Two-port |
|---|---|---|
| Started | 8 | 12 |
| Completed | 8 | 12 |
| Not completed | 0 | 0 |
The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared
| Participants | One-port | Two-port |
|---|---|---|
| Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant | 8 | 12 |
Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study
| Participants | One-port | Two-port |
|---|---|---|
| Number of Participants Who Required Additional Intervention | 1 | 4 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| One-port | — | 1/8 (12.5%) | 0/8 (0%) |
| Two-port | — | 4/12 (33.3%) | 0/12 (0%) |
| Event | One-port | Two-port |
|---|---|---|
| re-operationSurgical and medical procedures | 1/8 | 4/12 |
| Age, Categorical(Participants) | One-port | Two-port | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 17 |
| >=65 years | 0 | 3 | 3 |
| Age, Continuous(years) | One-port | Two-port | Total |
|---|---|---|---|
| Mean | 46.75 ± 12.28 | 51.08 ± 13.83 | 48.92 ± 3.06 |
| Sex: Female, Male(Participants) | One-port | Two-port | Total |
|---|---|---|---|
| Female | 8 | 12 | 20 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | One-port | Two-port | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | One-port | Two-port | Total |
|---|---|---|---|
| United States | 8 | 12 | 20 |
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Plan to share: No
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