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This is a multicenter, randomized, prospective, controlled study in patients having bilateral breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the treatment of surgical wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with KLOX BioPhotonic WoundGel System | Experimental | One breast will be randomized to be treated with KLOX BioPhotonic WoundGel System. |
|
| Treatment with silicone sheets | Active Comparator | The second breast will be randomized to be treated with silicone sheets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLOX BioPhotonic WoundGel System | Device | Patients will then be re-randomized to one of the three comparisons: treatment starting on day 7 post-surgery, treatment starting on Day 21 post-surgery, or two consecutive treatments applied once weekly. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events, Serious Adverse Events and Device Incidents | Number of patients with adverse events, serious adverse events and device incidents | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the patient and by the investigator via the POSAS | up to 24 weeks |
| Vancouver Scar Scale (VSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Park Medispa | Montreal | Quebec | H3Z1C3 | Canada | ||
| Westmount Aesthetic Surgery Centre |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Silicone sheets | Device | Treatment of the surgical wounds with silicone sheets. |
|
Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the investigator via the VSS
| up to 24 weeks |
| Efficacy as assessed by blinded experts panel | Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by a blinded experts committee | 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 |
| Montreal |
| Quebec |
| H3Z2M5 |
| Canada |