NovoX®Cup as Primary Dressing After Breast Reduction

NCT06420323 | Recruiting

• 1 other identifier: NOVOX CUP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing Disorder; Post-Surgical Complication; Mammaplasty

Keywords

Surgical wounds; Breast surgery; Plastic surgery; Oxygen-enriched oil; Dressing; Wound healing; Scar quality; postoperative complications; Breast reduction

Outcome Measures

Primary Outcomes (3)

• Scar quality (Vancouver Scar Scale, VSS)

  scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome

  2 weeks and 3 months after surgery.

• Scar quality (Patient and Observer Scar Assessment Scale, POSAS)

  scar quality measured through POSAS scale (total scores 6 to 60), higher scores indicate worse scar outcome

  2 weeks and 3 months after surgery.

• Wound healing disorder

  occurrence of wound healing disorders (yes/no)

  2-weeks and 3 months post-surgery

Secondary Outcomes (5)

• Pain (Numerical Scale Rating NRS)

  before surgery, 2-weeks and 3 months post-surgery

• Surgical Complications (Clavien-Dindo-Classification CDC)

  3 months post-surgery

• Breast-Q® Outcome

  before surgery, 2 weeks and 3 months post-surgery

• Breast-Q® breasts

  before surgery, 2 weeks and 3 months post-surgery

• Breast-Q® nipples

  before surgery, 2 weeks and 3 months post-surgery

Study Arms (2)

Treatment with NovoX® Cup

Patient gets treated with NovoX® Cup for 2 weeks.

Device: Treatment with NovoX® Cup

Treatment with Omnistrip®

Patient gets treated with Omnistrip® for 2 weeks.

Device: Treatment with Omnistrip®

Interventions

Treatment with NovoX® Cup DEVICE

NovoX® Cup treatment

Treatment with NovoX® Cup

Treatment with Omnistrip® DEVICE

Omnistrip® treatment

Treatment with Omnistrip®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients undergoing elective bilateral breast reduction surgery.

You may qualify if:

• Written informed consent
• Female patients 18 years and older
• Patient able to give informed consent
• Patients undergoing bilateral breast reduction

You may not qualify if:

• 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

Sponsors & Collaborators

• MOSS S.p.A.: lead

Study Sites (1)

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

Graz, A-8036, Austria

RECRUITING

MeSH Terms

Conditions

Surgical Wound; Postoperative Complications

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars-Peter Kamolz, Prof.

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Colombo, Ph.D.

CONTACT

+39 345 9070415; mcolombo@moss-info.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: July 25, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)