NovoX®Cup as Primary Dressing After Breast Reduction - Trial NCT06420323
Access comprehensive clinical trial information for NCT06420323 through Pure Global AI's free database. This phase not specified trial is sponsored by MOSS S.p.A. and is currently Not yet recruiting. The study focuses on Wound Healing Disorder,Post-Surgical Complication,Mammaplasty. Target enrollment is 20 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Treatment with NovoX® Cup
Interventional
device
Sponsor & Location
MOSS S.p.A.
Timeline & Enrollment
N/A
May 01, 2024
Apr 01, 2025
Primary Outcome
Scar quality (Vancouver Scar Scale, VSS),Scar quality (Patient and Observer Scar Assessment Scale, POSAS),Wound healing disorder
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06420323
Device Trial