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Breast Reconstruction clinical trials

View clinical trials related to Breast Reconstruction.

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NCT ID: NCT01216319 Completed - Breast Cancer Clinical Trials

Evaluation of the Cook Biodesign Plastic Surgery Matrix

NRC
Start date: September 2011
Phase: N/A
Study type: Interventional

Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK(r) Biodesign(r) Nipple Reconstruction Cylinder.

NCT ID: NCT01176786 Completed - Infections Clinical Trials

Reusable Versus Disposable Draping System in Breast Reconstruction Surgery

Start date: September 2009
Phase: N/A
Study type: Interventional

This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.

NCT ID: NCT01009008 Completed - Breast Cancer Clinical Trials

Patient Activated Controlled Expansion (PACE) Trial

PACE
Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

NCT ID: NCT01002014 Completed - Breast Cancer Clinical Trials

Nipple Sparing Mastectomy - Cosmetic Outcomes

Start date: January 21, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

NCT ID: NCT00905645 Completed - Clinical trials for Breast Reconstruction

Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Start date: November 2002
Phase: N/A
Study type: Interventional

Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

NCT ID: NCT00812097 Completed - Clinical trials for Breast Reconstruction

Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

CPG
Start date: February 2002
Phase: Phase 3
Study type: Interventional

The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

NCT ID: NCT00804674 Completed - Clinical trials for Breast Reconstruction

Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap

Start date: August 2005
Phase: Phase 2
Study type: Interventional

patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days

NCT ID: NCT00756652 Completed - Clinical trials for Breast Reconstruction

Mentor MemoryGel Post-Approval Study

MGPAS
Start date: November 1, 2006
Phase:
Study type: Observational

In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.

NCT ID: NCT00753922 Completed - Clinical trials for Breast Reconstruction

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

Start date: September 2000
Phase: Phase 3
Study type: Interventional

The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

NCT ID: NCT00727025 Completed - Clinical trials for Breast Reconstruction

Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure

Start date: July 2005
Phase: N/A
Study type: Interventional

Purpose: The aims of this randomized clinical trial are: 1. to assess scar quality from the patient and surgeon perspectives 2. to assess patient comfort in the days immediately following surgery 3. to assess the time taken to complete closure in the operating room. 4. the financial benefit or cost for the institution of using Steri Strip S will also be estimated. Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest. Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.