An observational study in Wound Healing Disorder, Post-Surgical Complication and Mammaplasty, sponsored by MOSS S.p.A.. Active, not recruiting at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by MOSS S.p.A. · Observational
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.
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.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's planned enrollment of 20 is below the median of 117 across 82 observational studies indexed under Surgical Wound.
Browse Surgical Wound studies →This is the only study on the registry with MOSS S.p.A. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Female patients undergoing elective bilateral breast reduction surgery.
Exclusion Criteria:
Patient gets treated with NovoX® Cup for 2 weeks.
Device: Treatment with NovoX® Cup
Patient gets treated with Omnistrip® for 2 weeks.
Device: Treatment with Omnistrip®
NovoX® Cup treatment
Omnistrip® treatment
Scar quality (Vancouver Scar Scale, VSS)
scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome
Time frame: 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
Time frame: 2 weeks and 3 months after surgery.
Wound healing disorder
occurrence of wound healing disorders (yes/no)
Time frame: 2-weeks and 3 months post-surgery
Pain (Numerical Scale Rating NRS)
Pain evaluated with Numerical Scale Rating (NRS score 0 to 10) higher score indicates worse pain
Time frame: 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
Time frame: 3 months post-surgery
Breast-Q® Outcome
Breast-Q® questionnaire satisfaction with outcome (scores 0 - 100 for each breast), higher score indicates greater satisfaction
Time frame: 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
Time frame: 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
Time frame: before surgery, 2 weeks and 3 months post-surgery
Plan to share: No
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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