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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.

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

Meso BioMatrix Device for Breast Reconstruction

Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial (NCT01823107)

Summary

Breast reconstruction after mastectomy is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. Surgeons have recently begun using a mesh derived from human cadaver skin to create a pocket for the tissue expander. The Meso BioMatrix Acellular Peritoneum Matrix is a new mesh that is similar to human skin and recently cleared by the FDA. This is a feasibility trial—a small study to evaluate how this mesh performs during breast reconstruction. The results of this trial, if successful, may be used to design a larger clinical trial in the future.
This is a Phase I-II trial

A Study of Two Types of Mesh That May Improve Breast Reconstruction

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial (NCT01310075)

Summary

Breast reconstruction with implants is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. During the second surgery, the expander is replaced with an implant(s). Researchers are studying new absorbable mesh products that can be used to support a breast implant as the tissue around it heals. The mesh may help reduce complications and improve appearance. AlloDerm® and SurgiMed® are two absorbable mesh products. AlloDerm is made with human cadaver skin. SurgiMed is made with calve skin. This study is comparing the appearance and rate of complication of breast reconstruction surgeries that use one of these mesh products with surgeries that do not use mesh. To be eligible, a patient must be scheduled to have a skin-sparing mastectomy with any of the surgeon co-investigators eligible for the study.

Quality of Life After Breast Reconstruction

Mastectomy Reconstruction Outcomes Consortium (MROC) Study (NCT01723423)

Summary

For many women, breast cancer surgery includes a mastectomy followed by breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium (MROC) has developed a web-based survey to help researchers learn more about how satisfied women are with their reconstructive surgery, what complications they experience, and how the surgery affects their psychological and emotional well-being and physical functioning. This study will evaluate the experiences of women who are having one of eight commonly used breast reconstruction surgeries at one of the 13 cancer centers that are part of the MROC.This study also is enrolling women without a history of breast cancer who are having a mastectomy to prevent breast cancer from occurring.

  • Participation Time5 online surveys
  • No Visits Required for this TrialNo travel required 

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