NovoX®Cup as Primary Dressing After Breast Reduction
Trial Parameters
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.
Eligibility Criteria
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