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

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.

Study Overview

• Status: Completed
• Conditions: Post-surgical Wounds
• Intervention / Treatment: Device: FBPM10 System; Other: Massages with vitamin E cream

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3Z1C3
      • Victoria Park Medispa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated written informed consent form;
2. Female 18 years of age and older;
3. 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;
4. Fitzpatrick skin type I to III;
5. 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;
6. Patients able to understand, willing and able to comply with all study requirements and post-operative instructions.

Exclusion Criteria:

1. Inability to understand the Study and its requirements or to give informed consent;
2. 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;
3. Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily);
4. Female pregnant patient (by medical history or as ascertained by a pregnancy test);
5. Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures;
6. 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;
7. Patients who are immunocompromised or taking immunosuppressive therapy;
8. Any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the Study investigational device;
9. 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;
10. Patients having had surgery in the area to be incised within one year of Study Screening;
11. Patients with tattoos in the areas of incisions;
12. Patients with history or familial history of keloids or hypertrophic scars;
13. Patients with incisions that are actively bleeding;
14. Patients with known skin hypersensitivity;
15. Patients with known allergic reactions to silicone.
16. Patients that cannot start the treatment within 14 days of the surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with FBPM10 system; One breast will be randomized to be treated with FBPM10 System.	Device: FBPM10 System; Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
Active Comparator: Treatment with standard of care; One breast will be selected to be treated with massages with vitamin E cream.	Other: Massages with vitamin E cream; The other breast will be treated with wound massages with vitamin E cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events, Serious adverse events, device incidents and compliance	Number of adverse events, serious adverse events, device incidents and missed treatment visits	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 24 weeks
Vancouver Scar Scale (VSS)	Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
External echography	Assessment of the aspect and depth of the dermal and epidermal superficial subcutaneous tissues in the two treatment groups	Up to 24 weeks

Collaborators and Investigators

• Sponsor: KLOX Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: CL-K1002-P011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No