Back to resultsEvaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
Primary Purpose
Post-surgical Wounds
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FBPM10 System
Massages with vitamin E cream
Sponsored by
About this trial
This is an interventional treatment trial for Post-surgical Wounds
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Victoria Park Medispa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment with FBPM10 system
Treatment with standard of care
Arm Description
One breast will be randomized to be treated with FBPM10 System.
One breast will be selected to be treated with massages with vitamin E cream.
Outcomes
Primary Outcome Measures
Adverse events, Serious adverse events, device incidents and compliance
Number of adverse events, serious adverse events, device incidents and missed treatment visits
Secondary Outcome Measures
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
Vancouver Scar Scale (VSS)
Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS
Ease of wound management
Patient's self-assessment of ease of wound management by a specific questionnaire
Full Information
NCT ID
NCT03271164
First Posted
August 29, 2017
Last Updated
February 25, 2019
Sponsor
KLOX Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03271164
Brief Title
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KLOX Technologies Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 System when compared with standard of care (massages with vitamin E cream) in the treatment of post-surgical wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with FBPM10 system
Arm Type
Experimental
Arm Description
One breast will be randomized to be treated with FBPM10 System.
Arm Title
Treatment with standard of care
Arm Type
Active Comparator
Arm Description
One breast will be selected to be treated with massages with vitamin E cream.
Intervention Type
Device
Intervention Name(s)
FBPM10 System
Intervention Description
Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
Intervention Type
Other
Intervention Name(s)
Massages with vitamin E cream
Intervention Description
The other breast will be treated with wound massages with vitamin E cream.
Primary Outcome Measure Information:
Title
Adverse events, Serious adverse events, device incidents and compliance
Description
Number of adverse events, serious adverse events, device incidents and missed treatment visits
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
Assessment of the efficacy of FBPM10 and standard of care by the patient and by the investigator via the POSAS
Time Frame
Up to 24 weeks
Title
Vancouver Scar Scale (VSS)
Description
Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS
Time Frame
Up to 24 weeks
Title
Ease of wound management
Description
Patient's self-assessment of ease of wound management by a specific questionnaire
Time Frame
Up to 24 weeks
Other Pre-specified Outcome Measures:
Title
External echography
Description
Assessment of the aspect and depth of the dermal and epidermal superficial subcutaneous tissues in the two treatment groups
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Victoria Park Medispa
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z1C3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
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