Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2018 |
| Start Date: | February 2016 |
| End Date: | January 2020 |
| Contact: | Lesley Wong, MD |
| Email: | lesley.wong@uky.edu |
| Phone: | 859-323-4263 |
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.
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.
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.
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
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