NovoX®Cup as Primary Dressing After Breast Reduction

NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mammaplasty; Wound Healing Disorder; Post-Surgical Complication
• Intervention / Treatment: Device: Treatment with NovoX® Cup; Device: Treatment with Omnistrip®

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.

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maurizio Colombo, Ph.D.; Phone Number: +39 345 9070415; Email: mcolombo@moss-info.it

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz
    • Contact: Lars-Peter Kamolz, Prof.; Phone Number: +43 316 385 14685; Email: Lars.kamolz@medunigraz.at
    • Principal Investigator: Lars P. Kamolz, Prof.
    • Sub-Investigator: Andrzej Hecker, Dr.med.univ.
    • Sub-Investigator: Maximilian Moshammer, Dr.med.univ.
    • Sub-Investigator: Anna-Lisa Pignet, Dr.med.univ.
    • Sub-Investigator: Marlies Schellnegger, Dr.med.univ.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients undergoing elective bilateral breast reduction surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment with NovoX® Cup; Patient gets treated with NovoX® Cup for 2 weeks.	Device: Treatment with NovoX® Cup; NovoX® Cup treatment
Treatment with Omnistrip®; Patient gets treated with Omnistrip® for 2 weeks.	Device: Treatment with Omnistrip®; Omnistrip® treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (Numerical Scale Rating NRS)	Pain evaluated with Numerical Scale Rating (NRS score 0 to 10) higher score indicates worse pain	before surgery, 2-weeks and 3 months post-surgery
Surgical Complications (Clavien-Dindo-Classification CDC)	Clavien-Dindo-Classification (CDC grade I to V) of surgical complications, higher grade indicates higher severity of the complications	3 months post-surgery
Breast-Q® Outcome	Breast-Q® questionnaire satisfaction with outcome (scores 0 - 100 for each breast), higher score indicates greater satisfaction	before surgery, 2 weeks and 3 months post-surgery
Breast-Q® breasts	Breast-Q® questionnaire satisfaction with breasts (scores 0 - 100 for each breast), higher score indicates greater satisfaction	before surgery, 2 weeks and 3 months post-surgery
Breast-Q® nipples	Breast-Q® questionnaire satisfaction with nipples (scores 0 - 100 for each breast), higher score indicates greater satisfaction	before surgery, 2 weeks and 3 months post-surgery

Collaborators and Investigators

• Sponsor: MOSS S.p.A.
• Investigators: Principal Investigator: Lars-Peter Kamolz, Prof., Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Wound healing; Dressing; Breast surgery; postoperative complications; Breast reduction; Plastic surgery; Scar quality; Surgical wounds; Oxygen-enriched oil
• Other Study ID Numbers: NOVOX CUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No