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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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.
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 →KLOX Technologies Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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The human immunodeficiency virus, which weakens the immune system.
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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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One breast will be randomized to be treated with FBPM10 System.
Device: FBPM10 System
One breast will be selected to be treated with massages with vitamin E cream.
Other: Massages with vitamin E cream
Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
The other breast will be treated with wound massages with vitamin E cream.
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
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
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
Ease of wound management
Patient's self-assessment of ease of wound management by a specific questionnaire
Time frame: Up to 24 weeks
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
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.
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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KLOX Technologies Inc.