Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420323
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-14
Brief Title:
NovoXCup as Primary Dressing After Breast Reduction
Sponsor:
MOSS SpA
Organization:
MOSS SpA
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 lifeHowever 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 reportedThe 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
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
Detailed Description:
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 11 ratio
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 11 ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None