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

NCT03271164 | Completed

• 1 other identifier: CL-K1002-P011
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient and Observer Scar Assessment Scale (POSAS)

  Up to 24 weeks

• Vancouver Scar Scale (VSS)

  Up to 24 weeks

• Ease of wound management

  Up to 24 weeks

Other Outcomes (1)

• External echography

  Up to 24 weeks

Study Arms (2)

Treatment with FBPM10 system

EXPERIMENTAL

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

Device: FBPM10 System

Treatment with standard of care

ACTIVE COMPARATOR

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

Other: Massages with vitamin E cream

Interventions

FBPM10 System DEVICE

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

Treatment with FBPM10 system

Massages with vitamin E cream OTHER

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

Treatment with standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (1)

Victoria Park Medispa

Montreal, Quebec, H3Z1C3, Canada

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: August 29, 2017
• Primary Completion: February 28, 2018
• Study Completion: June 30, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

CA (1)