Clinical trials: Breast Reconstruction Following Mastectomy
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery…
- Trial name
- NCT06512259
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- AlloSource
Breast Neoplasms
Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients.
- Trial name
- NCT06464913
- Testing
- With or without chest wall RT
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer Female
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
- Trial name
- RM2prepec (NCT04343820)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Institut Cancerologie de l'Ouest
Breast Cancer, Breast Reconstruction
Nipple Sparing Mastectomy - Cosmetic Outcomes
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.
- Conditions
- Breast Cancer, Breast Reconstruction, Cosmesis
- Trial name
- NCT01002014
- Testing
- Nipple Sparing Mastectomy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Pain, Postoperative, Breast Cancer
Speeding Recovery From Pain and Opioid Use
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living.
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Trial name
- NCT03388814
- Testing
- Local infiltration of bupivacaine, Pectoralis Nerve block
- Sponsor
- Wake Forest University Health Sciences
Breast Reconstruction Following Mastectomy
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.
- Trial name
- NCT04874402
- Testing
- Prepectoral approach, Partial Subpectoral approach
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
Post-Mastectomy Breast Deformity (Disorder)
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
- Trial name
- NCT05484934
- Testing
- Regenerative post mastectomy surgery
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- BioAesthetics
Breast Cancer Female, Breast Cancer Prevent
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
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…
- Conditions
- Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
- Trial name
- TIDE (NCT05460780)
- Testing
- MATTISSE TEC
- Where
- 3 sites in France, Georgia
- Volunteers
- 50 people
- Sponsor
- Quanta Medical
Breast Cancer, Chronic Pain
Persistent Pain After Reconstruction Following Mastectomy
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
- Trial name
- NCT01738048
- Testing
- Reconstruction
- Where
- Denmark
- Volunteers
- 1,352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Radiation Dermatitis, Skin Microbiome
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find…
- Conditions
- Radiation Dermatitis, Skin Microbiome, Breast Cancer, Reconstructive Surgery
- Trial name
- NCT05032768
- Testing
- post-operative radiotherapy
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Cancer, Capsular Contracture Associated With Breast Implant
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.
- Trial name
- PRETORIA (NCT04342546)
- Testing
- NovaGray RILA Breast® test
- Where
- 9 sites in France
- Volunteers
- 250 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Breast Cancer, BRCA1 Mutation
Depression and Body Image Distress Following Mastectomy With Reconstruction
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress.
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT03428399
- Testing
- Psychosocial variables
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
Seroma, Breast Cancer
Seroma of the Mammary Gland
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists).
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Trial name
- SerMa (NCT05899387)
- Testing
- Swap collection, Seroma punction, Blood sampling
- Where
- Germany
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Augsburg
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Breast Cancer
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator…
- Trial name
- NCT05301595
- Testing
- TAP block, QL Block
- Where
- Canada
- Sponsor
- Ottawa Hospital Research Institute
Breast Asymmetry Between Native Breast and Reconstructed Breast
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast…
- Trial name
- NCT02649283
- Testing
- OrbiSymm device, Breast symmetrisation
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Orbix Medical Ltd.
Seroma
Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy
Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.
- Trial name
- HOM (NCT03512639)
- Testing
- Homeopathic Medication
- Volunteers
- 55 people
- Sponsor
- Shaare Zedek Medical Center
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Breast Cancer
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion.
- Trial name
- NCT03541161
- Where
- South Korea
- Volunteers
- 115 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of…
- Trial name
- HIST-RIC (NCT02679040)
- Testing
- Immediate mammary reconstruction, Chemotherapy, Radiation therapy
- Where
- 10 sites in France
- Volunteers
- 101 people
- Sponsor
- Institut Paoli-Calmettes