Clinical trials: Breast Reconstruction
Ductal Carcinoma in Situ, Breast Cancer
Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions
This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery.
- Trial name
- NCT06903468
- Testing
- Novel cavity marking technique
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Florida
Breast Disease, Breast Cancer
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR).
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Trial name
- PROM-Q (NCT04842240)
- Testing
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Postoperative Pain, Breast Reconstruction
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and…
- Trial name
- NCT04777591
- Testing
- Liposomal bupivacaine TAP block, Bupivacain
- Where
- 2 sites in United States
- Volunteers
- 117 people
- Sponsor
- University of Virginia
Breast Cancer
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation…
- Trial name
- NCT05692674
- Testing
- adjuvant hypofractionated intensity-modulated proton radiotherapy
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Shanghai Proton and Heavy Ion Center
Mammary Gland Hyperplasia
Indications for Breast Reduction in the Public Health Care System
The overall purpose of the project is to create a scientific basis for which patients should be offered breast reduction in the public sector.
- Trial name
- NCT04889469
- Testing
- Breast reduction
- Where
- Sweden
- Volunteers
- 2,000 people
- Sponsor
- Vastra Gotaland Region
Hematoma Postoperative, Breast Cancer
Tranexamic Acid for Alloplastic Breast Reconstruction
Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources.
- Conditions
- Hematoma Postoperative, Breast Cancer, Tranexamic Acid
- Trial name
- NCT04918589
- Testing
- Tranexamic acid, Normal Saline
- Where
- 3 sites in Canada
- Volunteers
- 106 people
- Sponsor
- McMaster University
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Breast Cancer
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction
Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated…
- Trial name
- NCT04093999
- Testing
- Sensory nerve coaptation
- Where
- Netherlands
- Volunteers
- 126 people
- Sponsor
- Maastricht University Medical Center
Tissue Expander Based Breast Reconstruction
Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction
Infections after tissue expander breast reconstruction can lead to pain, additional surgeries, and loss of the reconstruction. This study will compare two types of antibiotic carriers used during surgery to help lower the risk of…
- Trial name
- NCT07339215
- Testing
- Antibiotic loaded calcium sulfate beads, Polymethylmethacrylate antibiotic disc
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Davis
Breast Reconstruction
Direct to Implant Breast Reconstruction Based Pre- or Retropectoral
The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two…
- Trial name
- NCT03143335
- Testing
- Retropectoral immediate breast reconstruction, Prepectoral immediate breast reconstruction
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Breast Cancer Female
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other…
- Trial name
- SCderm (NCT06553859)
- Testing
- No intervention conducts.
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- DOF Inc.
Breast Cancer Female, Surgery--Complications
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap.
- Trial name
- GoBreast (NCT03963427)
- Testing
- Breast reconstruction
- Volunteers
- 220 people
- Sponsor
- Vastra Gotaland Region
Breast Neoplasms, Fibrocystic Disease of Breast
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released from the adrenal gland.They are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable…
- Conditions
- Breast Neoplasms, Fibrocystic Disease of Breast, Mammaplasty
- Trial name
- NCT00310882
- Where
- Israel
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Breast Reconstruction, Breast Cancer
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022.
- Trial name
- NCT05943873
- Where
- Taiwan
- Volunteers
- 63 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used.
- Trial name
- NCT05316324
- Testing
- Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM), Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
- Where
- 2 sites in United States
- Volunteers
- 353 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Reconstruction
Melodi Matrix™ in Breast Reconstruction
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
- Trial name
- NCT06027996
- Testing
- Absorbable Antibacterial Matrix
- Where
- 10 sites in United States
- Volunteers
- 702 people
- Sponsor
- Melodi Health, Inc.
Mastectomy, Infections
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
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.
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Trial name
- NCT01176786
- Testing
- Culture Swabs, Rodac Plate Cultures
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer, Surgery
LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December…
- Trial name
- LIMBO (NCT06101732)
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Breast Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
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.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC