NovoX®Cup as Primary Dressing After Breast Reduction

MOSS S.p.A.

Status

Enrolling

Conditions

Wound Healing Disorder

Mammaplasty

Post-Surgical Complication

Treatments

Device: Treatment with NovoX® Cup

Device: Treatment with Omnistrip®

Study type

Observational

Funder types

Industry

Identifiers

NCT06420323

NOVOX CUP

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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