Clinical trial NCT06420323: NovoX®Cup as Primary Dressing After Breast Reduction
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: MOSS S.p.A.
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients undergoing elective bilateral breast reduction surgery.

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.

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

Primary outcomes:
measure: Scar quality (Vancouver Scar Scale, VSS)
timeFrame: 2 weeks and 3 months after surgery.
measure: Scar quality (Patient and Observer Scar Assessment Scale, POSAS)
timeFrame: 2 weeks and 3 months after surgery.
measure: Wound healing disorder
timeFrame: 2-weeks and 3 months post-surgery
Secondary outcomes:
measure: Pain (Numerical Scale Rating NRS)
timeFrame: before surgery, 2-weeks and 3 months post-surgery
measure: Surgical Complications (Clavien-Dindo-Classification CDC)
timeFrame: 3 months post-surgery
measure: Breast-Q® Outcome
timeFrame: before surgery, 2 weeks and 3 months post-surgery
measure: Breast-Q® breasts
timeFrame: before surgery, 2 weeks and 3 months post-surgery
measure: Breast-Q® nipples
timeFrame: before surgery, 2 weeks and 3 months post-surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Austria
name: Lars-Peter Kamolz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: