Mammaplasty Clinical Trial
Official title:
NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup
Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated. The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery.
A prospective intra-individually controlled cohort study. One breast will be chosen (left or right) to be treated with the NovoX®-Cup. The other breast will serve as the "standard of care" control. Randomization within this clinical investigation will be done intra-individually in a 1:1 ratio. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04329819 -
Satisfaction and QUality of Life After Breast REconstruction
|
||
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 | |
Completed |
NCT03016663 -
Volumetric Study of Fat Resorption After Breast Lipofilling
|
N/A | |
Completed |
NCT00227084 -
Effect of Arista Powder on Bleeding in Reductive Mammary Surgery
|
Phase 2 | |
Not yet recruiting |
NCT03240900 -
Electrical Stimulation for Improving Postoperative Breast Sensation
|
N/A | |
Recruiting |
NCT05171179 -
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
|
Phase 3 | |
Terminated |
NCT00432328 -
Juvista (Avotermin) in Breast Reduction Surgery Scars
|
Phase 2 | |
Active, not recruiting |
NCT04715802 -
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
|
||
Recruiting |
NCT03488888 -
PEC Block II in Mammoplasty Surgeries
|
N/A | |
Completed |
NCT03744273 -
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
|
N/A | |
Enrolling by invitation |
NCT03069885 -
iNPWT in Immediate Breast Reconstruction
|
N/A | |
Withdrawn |
NCT00310882 -
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
|
N/A | |
Recruiting |
NCT04891510 -
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
|
N/A | |
Recruiting |
NCT03118024 -
Perioperative Management of DIEP Flaps
|
N/A | |
Completed |
NCT04783818 -
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
|
||
Completed |
NCT04854525 -
Breast Reconstruction in Previously Irradiated Breast
|
||
Completed |
NCT04273464 -
Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
|
N/A | |
Not yet recruiting |
NCT02791672 -
Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
|
N/A | |
Completed |
NCT00616135 -
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
|
Phase 4 | |
Completed |
NCT00466765 -
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
|
N/A |