Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds

NCT ID: NCT03271164

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2018-06-30

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.

Conditions

Post-surgical Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with FBPM10 system

One breast will be randomized to be treated with FBPM10 System.

Group Type: EXPERIMENTAL

FBPM10 System

Intervention Type: DEVICE

Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.

Treatment with standard of care

One breast will be selected to be treated with massages with vitamin E cream.

Group Type: ACTIVE_COMPARATOR

Massages with vitamin E cream

Intervention Type: OTHER

The other breast will be treated with wound massages with vitamin E cream.

Interventions

FBPM10 System

Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.

Intervention Type: DEVICE

Massages with vitamin E cream

The other breast will be treated with wound massages with vitamin E cream.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KLOX Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Victoria Park Medispa

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CL-K1002-P011

Identifier Type: -

Identifier Source: org_study_id