Clinical trials: Breast Reconstruction Following Mastectomy
Breast Reconstruction, Deep Inferior Epigastric Perforator
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free…
- Conditions
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Breast Reconstruction After Mastectomy
- Trial name
- NCT07851415
- Testing
- Restrata®
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Pain
Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivered via pain pump to the…
- Trial name
- NCT01494259
- Testing
- Bupivacaine, Saline
- Where
- United States
- Sponsor
- Johns Hopkins University
Breast Reconstruction Following Mastectomy
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with…
- Trial name
- NCT07819357
- Testing
- Allogeneic Nerve Grafting
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Endeavor Health
Surgical Wound Infection
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
Surgical Site Infections (SSI) represents a significant complication in plastic surgery. Infections can result in a prolonged recovery and impair long-term cosmetic appearance.
- Trial name
- NCT02779296
- Testing
- 2-Octyl Cyanoacrylate Glue
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer, Breast Reconstruction
The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy
The outcomes of fat grafting combined with latissimus dorsi muscle flap for delayed breast reconstruction after mastectomy
- Trial name
- NCT07331753
- Testing
- Fat grafting combined with latissimus dorsi muscle flap
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Sohag University
Breast Cancer
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
- Trial name
- NCT06071234
- Testing
- 3D reconstruction technology
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Guangdong Provincial People's Hospital
Breast Cancer
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively.
- Trial name
- DELTI (NCT07757074)
- Testing
- Surgery options
- Where
- China
- Volunteers
- 268 people
- Sponsor
- Du Zhenggui
Breast Cancer, Breast Neoplasms, Breast Reconstruction
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Trial name
- REBORN (NCT07230535)
- Testing
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Where
- Ireland
- Volunteers
- 250 people
- Sponsor
- Beaumont Hospital
The Impact of Adipose Tissue Quality on Fat Graft Retention
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the…
- Trial name
- LipoTech (NCT05286424)
- Testing
- fat grafting
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Breast Neoplasms
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
- Trial name
- NCT06024187
- Testing
- Cold dissection, Electrocautery Dissection
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Implant Based Breast Reconstruction
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire.
- Trial name
- TIGR-Matrix (NCT06511167)
- Testing
- TIGR® Matrix
- Where
- 5 sites in Germany
- Volunteers
- 135 people
- Sponsor
- AWOgyn
Pre-Pectoral Breast Reconstruction Following Mastectomy
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
- Trial name
- NCT06853964
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- AlloSource
Breast Cancer, LCIS
Tumor: Breast Ratio Study
This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.
- Conditions
- Breast Cancer, LCIS, DCIS
- Trial name
- T:B (NCT02216136)
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Use of Dermal Matrix in Breast Reconstruction
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Trial name
- NCT00692692
- Testing
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University
Breast Cancer
Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Tissue Nanomechanical Phenotype Evaluation
To compare the outcomes of and responses to 2 different radiation therapy schedules (the standard radiation amount and number of doses versus less radiation and fewer doses) that are being given before having breast cancer…
- Trial name
- NCT05774678
- Testing
- Group 1 (preoperative radiation hypofractionated), Group 2 (preoperative radiation conventionally fractionated)
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- M.D. Anderson Cancer Center
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
Laser Speckle Imaging During Breast Reconstruction
Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation.
- Trial name
- SIMBAR (NCT06523452)
- Testing
- Laser Speckle Imaging
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Breast Cancer
Radiotherapy After Mastectomy for Breast Cancer Patients at Increased Risk of Local Recurrence
STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at increased risk of local relapse submitted to…
- Trial name
- NCT03101683
- Testing
- Partial chest wall radiation therapy
- Volunteers
- 28 people
- Sponsor
- Fondazione del Piemonte per l'Oncologia
Breast Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
Breast Cancer, Implant Breast Reconstruction
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based…
- Trial name
- NCT07835139
- Testing
- ConvRT, HypoRT
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University