Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective randomized controlled case series in patients having a surgery for bilateral breast reduction. Objectives of the case series are to evaluate the safety and efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E cream) in the treatment of post-surgical wounds.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with FBPM10 system | Experimental | One breast will be randomized to be treated with FBPM10 System. |
|
| Treatment with standard of care | Active Comparator | One breast will be selected to be treated with massages with vitamin E cream. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FBPM10 System | Device | Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Serious adverse events, device incidents and compliance | Number of adverse events, serious adverse events, device incidents and missed treatment visits | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | Assessment of the efficacy of FBPM10 and standard of care by the patient and by the investigator via the POSAS | Up to 24 weeks |
| Vancouver Scar Scale (VSS) |
| Measure | Description | Time Frame |
|---|---|---|
| External echography | Assessment of the aspect and depth of the dermal and epidermal superficial subcutaneous tissues in the two treatment groups | Up to 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Park Medispa | Montreal | Quebec | H3Z1C3 | Canada |
Not provided
| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Massages with vitamin E cream | Other | The other breast will be treated with wound massages with vitamin E cream. |
|
Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS
| Up to 24 weeks |
| Ease of wound management | Patient's self-assessment of ease of wound management by a specific questionnaire | Up to 24 weeks |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |