NovoX®Cup as Primary Dressing After Breast Reduction

NCT ID: NCT06420323

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment with NovoX® Cup

Patient gets treated with NovoX® Cup for 2 weeks.

Treatment with NovoX® Cup

Intervention Type: DEVICE

NovoX® Cup treatment

Treatment with Omnistrip®

Patient gets treated with Omnistrip® for 2 weeks.

Treatment with Omnistrip®

Intervention Type: DEVICE

Omnistrip® treatment

Interventions

Treatment with NovoX® Cup

NovoX® Cup treatment

Intervention Type: DEVICE

Treatment with Omnistrip®

Omnistrip® treatment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MOSS S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars-Peter Kamolz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Austria

Locations

Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Maurizio Colombo, Ph.D.

Role: CONTACT

mcolombo@moss-info.it

+39 345 9070415

Facility Contacts

Lars-Peter Kamolz, Prof.

Role: primary

Lars.kamolz@medunigraz.at

+43 316 385 14685

Other Identifiers

NOVOX CUP

Identifier Type: -

Identifier Source: org_study_id