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Breast Reconstruction clinical trials

View clinical trials related to Breast Reconstruction.

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NCT ID: NCT04331080 Completed - Clinical trials for Breast Reconstruction

A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery

Start date: July 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.

NCT ID: NCT04261608 Completed - Clinical trials for Breast Reconstruction

A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China

Start date: April 2, 2020
Phase:
Study type: Observational

This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).

NCT ID: NCT03743753 Completed - Clinical trials for Breast Reconstruction

Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster

RESTORE
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group. The control group will receive the current standard educational information from the surgeon along with an information package, while participants in the experimental group will also receive an additional education session before their operation about what to expect during their reconstructive journey. Satisfaction with care, anxiety about the procedure and recovery, and health related quality of life will be measured in all patients using established questionnaires. Additionally, feasibility outcomes will be reported and the results of this study will be used to demonstrate whether a larger version of this study can be successfully completed.

NCT ID: NCT03700970 Completed - Anesthesia Clinical Trials

Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

Start date: June 13, 2019
Phase: Phase 4
Study type: Interventional

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

NCT ID: NCT03376035 Completed - Clinical trials for Breast Reconstruction

Pilot Study Assessing Breast Temperature in Breast Cancer Patients

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.

NCT ID: NCT03064893 Completed - Clinical trials for Breast Reconstruction

The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

REaCT-ADM
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.

NCT ID: NCT03031457 Completed - Clinical trials for Venous Thromboembolism

Microsurgical Breast Reconstruction & VTE

Start date: January 30, 2017
Phase:
Study type: Observational

Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common cause of preventable in-hospital death as evidenced by over 100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial, with annual costs to the U.S. healthcare system in excess of $7 billion. Cancer patients have been identified as a particularly vulnerable patient population. Of these, breast cancer patients represent the largest group treated by plastic surgeons. An increasing number of breast reconstructions are performed in the U.S. with a documented 35% increase in the annual number of breast reconstructions since 2000. Over 106,000 breast reconstructions were performed in 2015 alone. Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is associated with the highest risk for VTE. We believe that a key element rendering these patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is supported by the observation that VTE risk remains elevated for up to 12 weeks postoperatively. We hypothesize that lower extremity deep venous system stasis is a procedure-specific key contributing factor to postoperative VTE risk. This study examines the duration of postoperative lower extremity venous stasis to identify patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging technology to examine the lower extremity deep venous system preoperatively, on postoperative day 1, and on the day of discharge to determine if patients display radiographic evidence of lower extremity venous stasis at the time of hospital discharge. A better understanding of pathophysiologic mechanisms that contribute to the development of VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE prophylaxis, thus, favorably impacting clinical outcome in a large patient population.

NCT ID: NCT02905149 Completed - Surgery Clinical Trials

Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery

Start date: August 2, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on postoperative analgesia.

NCT ID: NCT02563977 Completed - Clinical trials for Breast Reconstruction

Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

Start date: July 2015
Phase:
Study type: Observational

The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction. 14 women undergoing secondary, unilateral breast reconstruction were recruited to the study and underwent a 2 year postoperative CT scan of the abdomen (without contrast). Structural changes were assessed by comparing the abdominal CT scans performed prior to surgery with the 2 year postoperative CT scans.

NCT ID: NCT02481284 Completed - Clinical trials for Breast Reconstruction

Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure

Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this. Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).