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NovoX®Cup as Primary Dressing After Breast Reduction

NCT06420323 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Wound Healing Disorder
  • Post-Surgical Complication
  • Mammaplasty

Interventions

DEVICE

Treatment with NovoX® Cup

NovoX® Cup treatment

DEVICE

Treatment with Omnistrip®

Omnistrip® treatment

Sponsors & Collaborators

  • MOSS S.p.A.

    lead INDUSTRY

Principal Investigators

  • Lars-Peter Kamolz, Prof. · Medical University of Graz, Austria

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06420323 on ClinicalTrials.gov