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NCT Number: NCT06420323

NovoX®Cup as Primary Dressing After Breast Reduction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wound Healing Disorder Mammaplasty Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Surgical Complication Postoperative Complications Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Graz, A-8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with NovoX® Cup

Device

NovoX® Cup treatment

Treatment with Omnistrip®

Device

Omnistrip® treatment

Primary outcomes

  1. Scar quality (Vancouver Scar Scale, VSS)

    Time frame: 2 weeks and 3 months after surgery.

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

  2. Scar quality (Patient and Observer Scar Assessment Scale, POSAS)

    Time frame: 2 weeks and 3 months after surgery.

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

  3. Wound healing disorder

    Time frame: 2-weeks and 3 months post-surgery

    occurrence of wound healing disorders (yes/no)

Secondary outcomes

  1. Pain (Numerical Scale Rating NRS)

    Time frame: before surgery, 2-weeks and 3 months post-surgery

    Pain evaluated with Numerical Scale Rating (NRS score 0 to 10) higher score indicates worse pain

  2. Surgical Complications (Clavien-Dindo-Classification CDC)

    Time frame: 3 months post-surgery

    Clavien-Dindo-Classification (CDC grade I to V) of surgical complications, higher grade indicates higher severity of the complications

  3. Breast-Q® Outcome

    Time frame: before surgery, 2 weeks and 3 months post-surgery

    Breast-Q® questionnaire satisfaction with outcome (scores 0 - 100 for each breast), higher score indicates greater satisfaction

  4. Breast-Q® breasts

    Time frame: before surgery, 2 weeks and 3 months post-surgery

    Breast-Q® questionnaire satisfaction with breasts (scores 0 - 100 for each breast), higher score indicates greater satisfaction

  5. Breast-Q® nipples

    Time frame: before surgery, 2 weeks and 3 months post-surgery

    Breast-Q® questionnaire satisfaction with nipples (scores 0 - 100 for each breast), higher score indicates greater satisfaction

Sponsors and collaborators

Lead sponsor

MOSS S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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