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Breast Reconstruction clinical trials

View clinical trials related to Breast Reconstruction.

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NCT ID: NCT05600153 Not yet recruiting - Clinical trials for Breast Reconstruction

Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

AvBSR
Start date: December 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.

NCT ID: NCT05585710 Recruiting - Clinical trials for Breast Reconstruction

Pulsed Lavage in Implant-Based Breast Reconstruction

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

NCT ID: NCT05491473 Completed - Clinical trials for Breast Reconstruction

Negative Pressure in PAP Donor Sites

Start date: September 23, 2021
Phase:
Study type: Observational

A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. The included patients will be grouped into two according to the application of incisional negative pressure wound therapy (NP) on the donor site. Patients' demographic data including their age at the surgery, body mass index (BMI), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. Parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. The major interest is in the donor site management and patient's overall recovery. The complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. Donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. The cutting time point for acute and chronic complications is 1 month. The total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. Besides, for patients with follow up time of more than 1 year, the scar will be evaluated using Vancouver scar scale. Statistics Data will be analyzed using graphing and statistical analysis software SPSS 21 software (IBM, Chicago, Illinois, USA). Rank sum and independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant. Potential risks: No Confidentiality: All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.

NCT ID: NCT05460780 Recruiting - Clinical trials for Breast Cancer Female

First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer

TIDE
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.

NCT ID: NCT05388240 Completed - Clinical trials for Breast Reconstruction

Shoulder Rehabilitation Using a Mobile App Following Breast Reconstruction

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer for Canadian women. Of the women who will have a mastectomy each year in Canada, one in five will elect to have breast reconstruction. However, the significant benefits for body-image, self-esteem, sexuality, and quality of life are tempered by post-treatment shoulder dysfunction for many. As a means to decrease shoulder morbidities in breast cancer survivors (BCS), this study will introduce a mobile application (app)-based shoulder rehabilitation program as an option to improve functional outcomes of the shoulder, for those who have had breast reconstruction.

NCT ID: NCT05377723 Recruiting - Clinical trials for Breast Reconstruction

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.

NCT ID: NCT05363189 Recruiting - Breast Cancer Clinical Trials

Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)

BestDIEP
Start date: May 2, 2022
Phase:
Study type: Observational

Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than some other methods, such as implant-based techniques. The main objectives of the present study are to investigate if pre- peri- and postoperative protocols can be safely modified, so the operation demands less resources, while maintaining a low complication rate and a high patient satisfaction.

NCT ID: NCT05206565 Not yet recruiting - Clinical trials for Breast Reconstruction

Effect of Neurotization on QoL and Sensory Restoration

Start date: June 2024
Phase: N/A
Study type: Interventional

This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.

NCT ID: NCT05028101 Terminated - Clinical trials for Breast Reconstruction

The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction.

NCT ID: NCT04992650 Enrolling by invitation - Clinical trials for Breast Reconstruction

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).