Trials / Completed
CompletedNCT02604251
Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
A Prospective Randomized Clinical Study Evaluating the Safety and Efficacy of the KLOX BioPhotonic WoundGel System When Compared With Silicone Sheets in the Treatment of Surgical Wounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- KLOX Technologies Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | KLOX BioPhotonic WoundGel System | 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. |
| DEVICE | Silicone sheets | Treatment of the surgical wounds with silicone sheets. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-04-01
- Completion
- 2017-11-01
- First posted
- 2015-11-13
- Last updated
- 2018-03-06
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02604251. Inclusion in this directory is not an endorsement.