Using NovoX®Cup for wound care after breast reduction surgery
NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup
This study tests if a new wound dressing called the NovoX® Cup helps heal better after breast reduction surgery compared to standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | MOSS S.p.A. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Graz) |
| Trial ID | NCT06420323 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the NovoX® Cup, a novel wound dressing, in promoting healing after breast reduction surgery. In this intra-individual controlled cohort study, one breast will be treated with the NovoX® Cup while the other will receive standard care, allowing for direct comparison of outcomes. The dressing is designed to fit the breast anatomy and is coated with oxygen-enriched oil to enhance healing. The study aims to assess the incidence of postoperative complications such as wound disorders.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older who are undergoing bilateral breast reduction.
Not a fit: Patients with a history of breast cancer or those currently undergoing treatment for active malignant disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved wound healing and reduced complications for patients undergoing breast reduction surgery.
How similar studies have performed: Previous studies have shown promising results with the NovoX® Cup in similar surgical contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz
- Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz — Graz, Austria (Recruiting)
Study contacts
- Principal investigator: Lars-Peter Kamolz, Prof. — Medical University of Graz
- Study coordinator: Maurizio Colombo, Ph.D.
- Email: mcolombo@moss-info.it
- Phone: +39 345 9070415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.