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Surgery: Reconstruction

Nipple-Sparing Mastectomy

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy (NCT01002014)

Summary

Many women choose to have a skin-sparing mastectomy when they have immediate breast reconstruction. During a traditional skin-sparing mastectomy, all of the breast skin is preserved, except for the nipple and areola. Nipple-sparing mastectomy is a procedure that allows women to keep their nipple and areola as well. The goal of this study is to observe the cosmetic outcomes, patient satisfaction, and complications of nipple-sparing mastectomy. To be eligible, women must be planning to have either a therapeutic or prophylactic mastectomy.

What's Involved    Contact information

Comparing Two Types of Tissue Expanders for Breast Reconstruction

Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction (NCT02725801)

Summary

During breast reconstruction, a tissue expander is put into the chest wall. The expander is filled with saline (salt water) through a port to gradually stretch the skin and make space for the implant. The traditional type of expander has one port. AlloX2® is a new type of expander that has two ports: one port fills the expander and the other drains seroma, the clear bodily fluids that develops where the breast has been removed. In this study, half of the women will receive the regular one-port expander and the other half will receive the two-port expander. This will allow the researcher to see whether women have a better outcome or less complications when using a one-port or two-port expander. To be eligible, a woman must be planning to have immediate tissue expander breast reconstruction following her mastectomy.

  • Participation TimeCoincides with breast reconstruction
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Two Different Incision Sites For Skin-Sparing Mastectomy With Immediate Reconstruction

A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction (NCT01969448)

Summary

Incisions for skin-sparing mastectomies can be made in different places. Inframammary fold incisions are made in the crease under the breast and hidden in a natural skin fold. Lateral radial incisions start at the nipple and extend from the center to the outer edge. This study is investigating whether an inframammary fold incision or a lateral radial incision provides the best blood supply to the skin envelope during a nipple-sparing mastectomy with immediate reconstruction. To be eligible, participants must be scheduled to have either a single or bilateral elective nipple-areola skin sparing mastectomy with planned immediate reconstruction.

What's Involved    Contact information

Studying Tumor-to-Breast Ratio in Patients with DCIS or Early-Stage Breast Cancer

A Prospective Trial to AssessTumor:Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction (NCT02216136)

Summary

The size of the tumor compared to the size of the breast is referred to as the tumor-to-breast volume ratio. The ratio is a factor in whether a woman has the option of having a lumpectomy. In this study, women who are scheduled to undergo lumpectomy, mastectomy, or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage breast cancer will have a breast MRI that determines their tumor-to-breast volume ratio prior to surgery. After surgery, patients will complete questionnaires designed to assess their quality of life.

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Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

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Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial

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