Clinical trials: Breast Reconstruction Surgery
Perioperative Fluid Management
Comparison of Hemodynamic Results of Two Different Fluid Managements
In the reduction mammoplasty operations performed in the Plastic and Reconstructive surgery operating room in our clinic, the female patient group, who does not have co-morbidities and does not exceed middle age, is followed by…
- Trial name
- NCT05733403
- Testing
- isotonic solution, Noradrenaline
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Istanbul University
Mammoplasty, Scarring
A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
- Conditions
- Mammoplasty, Scarring, Scar, Breast Reconstruction
- Trial name
- NCT04331080
- Testing
- Granexin® gel 100 μM, Granexin® gel 200 μM, Vehicle gel
- Where
- 11 sites in United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Xequel Bio, Inc.
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Breast Cancer, Surgery
Evaluation of ADM Soft Tissue Reinforcement
The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement.
- Conditions
- Breast Cancer, Surgery, Surgical Item, Retained
- Trial name
- NCT03494244
- Testing
- Direct-to-implant breast reconstruction, Acellular dermal matrix
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Breast/Surgery
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon. 2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated…
- Trial name
- NCT05560633
- Testing
- No intervention
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Surgical Site Infection
Dressing Wear Time After Breast Augmentation With Prosthesis
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
- Trial name
- NCT01553604
- Testing
- augmentation mammaplasty
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daniela Francescato Veiga
Breast Cancer
BREAST Choice Decision Tool R21 - AIM2
Breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy.
- Trial name
- BREASTChoice (NCT06817226)
- Testing
- Pre-survey, BREASTChoice tool., Post-survey
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Braest Cancer, Breast Reconstruction
Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction
Breast reconstruction is an important step and option after mastectomy and can help improve the quality of life of breast cancer patients.
- Trial name
- NCT06552650
- Testing
- Exercise, Usual Care
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Postoperative Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
Breast Cancer, Gynecologic Cancer
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient…
- Trial name
- ERAS-OncoRe (NCT03456167)
- Testing
- RecoverWell mobile app for follow-up care
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Alberta Health Services, Calgary
Breast Cancer, Quality of Life
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk.
- Conditions
- Breast Cancer, Quality of Life, Surgery--Complications
- Trial name
- PreQ-20 (NCT04642508)
- Testing
- Prepectoral reconstruction
- Where
- Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University Hospital A Coruña
Reconstructive Surgical Procedures
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping.
- Trial name
- NCT04115995
- Testing
- Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital of North Norway
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Recurrent Ptosis of the Breast
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or…
- Trial name
- SeriSupport (NCT02016612)
- Testing
- Seri Surgical Scaffold
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bengtson Center
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Cancer
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an…
- Trial name
- NCT00734838
- Testing
- High Resolution Microendoscope
- Where
- United States
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Duke University
Respiratory Function, Breast Reconstruction
The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions
This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month…
- Trial name
- NCT02491762
- Testing
- respiratory function tests
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Yaron Har-Shai
Bacterial Infection, Anti-infective Agents
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures.
- Conditions
- Bacterial Infection, Anti-infective Agents, Breast Implantation
- Trial name
- NCT01244698
- Testing
- Cefadroxil discontinued early, Cefadroxil until drain removal
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
Breast Cancer, Ductal Carcinoma in Situ
The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.
The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia…
- Trial name
- NCT04248179
- Testing
- Ropivacaine injection, Saline 0.9%, Sufentanil and PONV prophylaxis
- Where
- Denmark
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zealand University Hospital