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CompletedNCT03271164Updated Feb 26, 2019

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

An interventional study of FBPM10 System and Massages with vitamin E cream in Post-surgical Wounds, sponsored by KLOX Technologies Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by KLOX Technologies Inc. · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Post-surgical Wounds

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03

In context

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

This study's enrollment of 5 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

KLOX Technologies Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated written form;
  2. Female 18 years of age and older;
  3. Good general health, stable weight, free of systemic diseases such as diabetes, arthritis, 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

Exclusion Criteria:

  1. Inability to understand the Study and its requirements or to give ;
  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 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 device;
  9. Patient has ongoing malignant disease of any type, active systemic, local skin infection or disease, 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 ;
  15. Patients with known allergic reactions to silicone.
  16. Patients that cannot start the treatment within 14 days of the surgery.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Treatment with FBPM10 system

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

    Device: FBPM10 System

  • 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

Interventions

  • DeviceFBPM10 System

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

  • OtherMassages with vitamin E cream

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

06

What researchers measure

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

    Time frame: Up to 24 weeks

Secondary outcomes

  1. 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

    Time frame: Up to 24 weeks

  2. Vancouver Scar Scale (VSS)

    Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS

    Time frame: Up to 24 weeks

  3. Ease of wound management

    Patient's self-assessment of ease of wound management by a specific questionnaire

    Time frame: Up to 24 weeks

Other outcomes

  1. External echography

    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

07

Study locations

1 site
  • Victoria Park Medispa
    Montreal, Quebec H3Z1C3, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Feb 2018, 5 months.

Of 27 industry-sponsored interventional studies with no phase under Surgical Wound, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 5 months is below that.

Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 1, 2017
StartActual
Aug 29, 2017
Primary completionActual
Feb 28, 2018
CompletionActual
Jun 30, 2018
Last update
Feb 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03271164
Lead sponsor
KLOX Technologies Inc.
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Aug 29, 2017
Primary completion
Feb 28, 2018
Completion
Jun 30, 2018
Last update
Feb 26, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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