Clinical trials: Breast Reconstruction
Tissue Expansion, Implant Based Breast Reconstruction
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order…
- Trial name
- NCT05975372
- Testing
- Blossom tissue expander, Standard tissue expansion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
- Trial name
- NCT00691327
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 84,329 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
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.
Skin Barrier to Water Loss, Skin Health
Apple Peptide Complex for Post-Surgical and Aesthetic Skin Recovery
This clinical study evaluates a topical botanical formulation for supporting skin recovery following invasive and non-invasive aesthetic procedures.
- Conditions
- Skin Barrier to Water Loss, Skin Health, Skin Discoloration, Skin Irritation
- Trial name
- APC-SKIN (NCT07807085)
- Testing
- Apple Peptide Complex Post-Aesthetic Care Protocol
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Grow Out Oils Clinical Aromatherapy Company
Sexual Function, Depression
Sexuality After Reduction Mammaplasty
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.
- Trial name
- NCT01020422
- Testing
- Reduction mammaplasty
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Daniela Francescato Veiga
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
Bariatric Surgery, Abdominoplasty
Effect of a Collagen-containing Supplement on Dermal Collagen Content in Metabolic Bariatric Surgery Patients Undergoing Corrective Aesthetic Surgery: A Randomized, Double-blind, Placebo-controlled Trial
This single-center, randomized, placebo-controlled trial evaluated whether perioperative supplementation with a collagen-based oral formulation affected dermal collagen content and postoperative outcomes in adults aged 18-65…
- Conditions
- Bariatric Surgery, Abdominoplasty, Collagen Synthesis, Skin Physiology
- Trial name
- COLLAGEN (NCT06787924)
- Testing
- Collagen hydrolyzed peptides, Starch
- Where
- Egypt
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
Breast Reconstruction
Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap
patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within…
- Trial name
- NCT00804674
- Testing
- bupivacain
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Ullevaal University Hospital
Breast Reduction, Reduction Mammoplasty
Risk of Hematoma After Ketorolac Use in Reduction Mammoplasty.
The investigators hope to answer the question, "does ketorolac increase the risk of hematoma after reduction mammoplasty?" using a case-control study.
- Conditions
- Breast Reduction, Reduction Mammoplasty, Hematoma, Hemorrhage
- Trial name
- NCT03280043
- Testing
- Hematoma
- Where
- 2 sites in Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- McMaster University
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
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01870869
- Testing
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Where
- 58 sites in United States
- Volunteers
- 1,951 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Infections, Quality of Life
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection.
- Trial name
- NCT05846438
- Testing
- Showering 48 hours after surgery
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
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, 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
Abdominoplasty, Breast Reduction
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
The aim of this pilot study is to evaluate the potential benefits of nutrient supplementation on post-operative recovery for patients undergoing certain types of surgery, compared to those who do not receive such supplementation.
- Conditions
- Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction, Body Contouring Surgery
- Trial name
- R-Support (NCT06601868)
- Testing
- R-Support Prepare & After nutritional supplement
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
Hypertrophic Scar
Role of Topical Putrescine (Fibrostat) for Prevention of Hypertrophic Scars in Mammoplasty Patients
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application.
- Trial name
- NCT03376620
- Testing
- 1,4-Diaminobutane, 10% Urea cream
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Breast Cancer, Pain, Postoperative
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast…
- Conditions
- Breast Cancer, Pain, Postoperative, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT01591746
- Testing
- Botulinum Toxin Type A
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic