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Clinical Trial

NovoX®Cup as Primary Dressing After Breast Reduction

NCT: NCT06420323 · ACTIVE_NOT_RECRUITING

NCT IDNCT06420323
StatusACTIVE_NOT_RECRUITING
Start Date2024-07-25
Completion2026-07

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.

Frequently Asked Questions

What is NovoX®Cup as Primary Dressing After Breast Reduction?

NovoX®Cup as Primary Dressing After Breast Reduction is a clinical trial registered under NCT06420323. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT06420323?

The current status of NCT06420323 (NovoX®Cup as Primary Dressing After Breast Reduction) is: ACTIVE_NOT_RECRUITING.

When did NovoX®Cup as Primary Dressing After Breast Reduction start?

NovoX®Cup as Primary Dressing After Breast Reduction started on 2024-07-25.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.