## Protocol Section
### Identification Module
**NCT ID:** NCT06420323

**Brief Title:** 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

#### Organization Study ID Info
**ID:** NOVOX CUP
#### Organization
**Class:** INDUSTRY
**Full Name:** MOSS S.p.A.
### Status Module
#### Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MOSS S.p.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient gets treated with NovoX® Cup for 2 weeks.

**Intervention Names:**

- Device: Treatment with NovoX® Cup

**Label:** Treatment with NovoX® Cup

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patient gets treated with Omnistrip® for 2 weeks.

**Intervention Names:**

- Device: Treatment with Omnistrip®

**Label:** Treatment with Omnistrip®

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment with NovoX® Cup

**Description:** NovoX® Cup treatment

**Name:** Treatment with NovoX® Cup

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Treatment with Omnistrip®

**Description:** Omnistrip® treatment

**Name:** Treatment with Omnistrip®

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Scar quality (Vancouver Scar Scale, VSS)

**Time Frame:** 2 weeks and 3 months after surgery.

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

**Measure:** Scar quality (Patient and Observer Scar Assessment Scale, POSAS)

**Time Frame:** 2 weeks and 3 months after surgery.

**Description:** occurrence of wound healing disorders (yes/no)

**Measure:** Wound healing disorder

**Time Frame:** 2-weeks and 3 months post-surgery

#### Secondary Outcomes

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

**Measure:** Pain (Numerical Scale Rating NRS)

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

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

**Measure:** Surgical Complications (Clavien-Dindo-Classification CDC)

**Time Frame:** 3 months post-surgery

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

**Measure:** Breast-Q® Outcome

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

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

**Measure:** Breast-Q® breasts

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

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

**Measure:** Breast-Q® nipples

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

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mcolombo@moss-info.it

**Name:** Maurizio Colombo, Ph.D.

**Phone:** +39 345 9070415

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Graz

**Contacts:**

***Contact 1:***

- **Email:** Lars.kamolz@medunigraz.at

- **Name:** Lars-Peter Kamolz, Prof.

- **Phone:** +43 316 385 14685

- **Role:** CONTACT

***Contact 2:***

- **Name:** Lars P. Kamolz, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Andrzej Hecker, Dr.med.univ.

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Maximilian Moshammer, Dr.med.univ.

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Anna-Lisa Pignet, Dr.med.univ.

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Marlies Schellnegger, Dr.med.univ.

- **Role:** SUB_INVESTIGATOR

**Country:** Austria

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

**Zip:** A-8036

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of Graz, Austria

**Name:** Lars-Peter Kamolz, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M1112

- Name: Surgical Wound

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
