Trials / Completed
CompletedNCT03271164
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
Prospective Randomized Controlled Case Series Evaluating the Safety and Efficacy of FBPM10 System When Compared to Standard of Care in the Treatment of Post-surgical Wounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- KLOX Technologies Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FBPM10 System | Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp. |
| OTHER | Massages with vitamin E cream | The other breast will be treated with wound massages with vitamin E cream. |
Timeline
- Start date
- 2017-08-29
- Primary completion
- 2018-02-28
- Completion
- 2018-06-30
- First posted
- 2017-09-01
- Last updated
- 2019-02-26
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03271164. Inclusion in this directory is not an endorsement.