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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with NovoX® Cup | Patient gets treated with NovoX® Cup for 2 weeks. |
| |
| Treatment with Omnistrip® | Patient gets treated with Omnistrip® for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with NovoX® Cup | Device | NovoX® Cup treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Wound healing disorder | occurrence of wound healing disorders (yes/no) | 2-weeks and 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surgical Complications (Clavien-Dindo-Classification CDC) |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients undergoing elective bilateral breast reduction surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Peter Kamolz, Prof. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz | Graz | A-8036 | Austria |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment with Omnistrip® |
| Device |
Omnistrip® treatment |
|
Clavien-Dindo-Classification (CDC grade I to V) of surgical complications, higher grade indicates higher severity of the complications
| 3 months post-surgery |
| 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 |
| 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 |
| 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 |