Status:
COMPLETED
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
Lead Sponsor:
KLOX Technologies Inc.
Conditions:
Post-surgical Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent form;
- Female 18 years of age and older;
- Good general health, stable weight, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment;
- Fitzpatrick skin type I to III;
- Patients with bilateral breast reduction, expected to have newly formed post-surgery breast incisions of comparable length and of comparable appearance, located on comparable skin area;
- Patients able to understand, willing and able to comply with all study requirements and post-operative instructions.
Exclusion
- Inability to understand the Study and its requirements or to give informed consent;
- Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to Treatment initiation;
- Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (\> 162 mg daily);
- Female pregnant patient (by medical history or as ascertained by a pregnancy test);
- Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures;
- Patient with known photosensitivity, taking drug(s) to treat photosensitivity, with concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin;
- Patients who are immunocompromised or taking immunosuppressive therapy;
- Any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the Study investigational device;
- Patient has ongoing malignant disease of any type, active systemic, local skin infection or disease, autoimmune disease or any significant chronic disease which, in the opinion of the investigator, might interfere with the evaluation of the Study objectives or would result in non-compliance with the Study protocol;
- Patients having had surgery in the area to be incised within one year of Study Screening;
- Patients with tattoos in the areas of incisions;
- Patients with history or familial history of keloids or hypertrophic scars;
- Patients with incisions that are actively bleeding;
- Patients with known skin hypersensitivity;
- Patients with known allergic reactions to silicone.
- Patients that cannot start the treatment within 14 days of the surgery.
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03271164
Start Date
August 29 2017
End Date
June 30 2018
Last Update
February 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Victoria Park Medispa
Montreal, Quebec, Canada, H3Z1C3