NovoX®Cup as Primary Dressing After Breast Reduction

Launched by MOSS S.P.A. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a new type of wound dressing called NovoX® Cup after breast reduction surgery. Breast reduction is a common surgery that can greatly improve a woman’s quality of life, but sometimes patients experience complications like wound healing problems. The NovoX® Cup is designed to fit the shape of the breast and has special features to promote healing. This trial aims to find out if using the NovoX® Cup leads to better healing, fewer complications, and more satisfied patients compared to standard wound dressings.

To participate in this study, women 18 years and older who are planning to have breast reduction surgery may be eligible, provided they can give informed consent and do not have certain health conditions, such as a recent history of cancer or skin issues in the surgery area. Participants will be monitored for two weeks and then three months after their surgery to see how well they heal and how they feel about the results. This is an important opportunity to explore a new option for wound care that could improve recovery after breast reduction surgery.

Gender

FEMALE

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