NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Wound healing disorder
Study Overview
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 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.
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 1:1 ratio.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent
- •Female patients 18 years and older
- •Patient able to give informed consent
- •Patients undergoing bilateral breast reduction
Exclusion Criteria
- •Absent informed consent
- •Patients from protected groups and those who are not personally able to give consent.
- •Patients younger than 18 years
- •Pregnancy (pregnancy test before enrollment) and breastfeeding women
- •Former radiation of the breast(s)
- •Former surgery at the operation site
- •Skin abnormalities in the operation area (e.g. burn scars)
- •Participation in other clinical trials during this study
- •Active malignant disease
- •Breast cancer history
- •Radiation or chemotherapy during the study period or up to 6 months before possible enrollment
- •Immune disease
Outcomes
Primary Outcomes
Wound healing disorder
Time Frame: 2-weeks and 3 months post-surgery
occurrence of wound healing disorders (yes/no)
Scar quality (Vancouver Scar Scale, VSS)
Time Frame: 2 weeks and 3 months after surgery.
scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome
Scar quality (Patient and Observer Scar Assessment Scale, POSAS)
Time Frame: 2 weeks and 3 months after surgery.
scar quality measured through POSAS scale (total scores 6 to 60), higher scores indicate worse scar outcome
Secondary Outcomes
- Pain (Numerical Scale Rating NRS)(before surgery, 2-weeks and 3 months post-surgery)
- Breast-Q® breasts(before surgery, 2 weeks and 3 months post-surgery)
- Breast-Q® nipples(before surgery, 2 weeks and 3 months post-surgery)
- Surgical Complications (Clavien-Dindo-Classification CDC)(3 months post-surgery)
- Breast-Q® Outcome(before surgery, 2 weeks and 3 months post-surgery)