NovoX®Cup as Primary Dressing After Breast Reduction

Mammaplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420323
• Other study ID #: NOVOX CUP
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: MOSS S.p.A.
• Contact: Maurizio Colombo, Ph.D.
• Phone: +39 345 9070415
• Email: mcolombo[@]moss-info.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mammaplasty
• Wound Healing Disorder

Intervention

Device:
• Treatment with NovoX® Cup
NovoX® Cup treatment
• Treatment with Omnistrip®
Omnistrip® treatment

Locations

Country	Name	City	State
Austria	Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
MOSS S.p.A.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Wound healing disorder	occurrence of wound healing disorders (yes/no)	2-weeks and 3 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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