NCT06420323

NovoX®Cup as Primary Dressing After Breast Reduction

NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: MOSS S.p.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Healing Disorder
• Post-Surgical Complication
• Mammaplasty

Interventions

Type	Name	Description
DEVICE	Treatment with NovoX® Cup	NovoX® Cup treatment
DEVICE	Treatment with Omnistrip®	Omnistrip® treatment

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-05-20
• Last updated: 2025-04-10

Locations

1 site across 1 country: Austria