Post-surgical WoundsNCT03271164
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
A study testing FBPM10 System and Massages with vitamin E cream in people with Post-surgical Wounds, run by KLOX Technologies Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-surgical Wounds
- What is being tested?
- FBPM10 System and Massages with vitamin E cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 29 Aug 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- Patients that cannot start the treatment within 14 days of the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-surgical Wounds
- Being tested
- FBPM10 System, Massages with vitamin E cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBPM10 SystemDevice
Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
Massages with vitamin E creamOther
The other breast will be treated with wound massages with vitamin E cream.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with FBPM10 system | Experimental | One breast will be randomized to be treated with FBPM10 System. Receives: Device: FBPM10 System |
| Treatment with standard of care | Active comparator | One breast will be selected to be treated with massages with vitamin E cream. Receives: Other: Massages with vitamin E cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Serious adverse events, device incidents and compliance
Number of adverse events, serious adverse events, device incidents and missed treatment visits
Measured: Up to 24 weeks
Secondary outcomes (3)
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
Measured: Up to 24 weeks
Vancouver Scar Scale (VSS)
Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS
Measured: Up to 24 weeks
Ease of wound management
Patient's self-assessment of ease of wound management by a specific questionnaire
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start29 Aug 2017
- Primary completion28 Feb 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271164
- Sponsor's protocol ID
- CL-K1002-P011
- Status last verified
- Feb 2019
- First submitted
- 29 Aug 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03271164
- Acronym / sponsor ID
- CL-K1002-P011
- Conditions
- Post-surgical Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with FBPM10 system | Experimental | Device: FBPM10 SystemOne breast will be randomized to be treated with FBPM10 System. |
| Treatment with standard of care | Active comparator | Other: Massages with vitamin E creamOne breast will be selected to be treated with massages with vitamin E cream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FBPM10 SystemApplication of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp. | Device | Treatment with FBPM10 system |
| Massages with vitamin E creamThe other breast will be treated with wound massages with vitamin E cream. | Other | Treatment with standard of care |
Primary outcome
Adverse events, Serious adverse events, device incidents and compliance
Time frame: Up to 24 weeks
Number of adverse events, serious adverse events, device incidents and missed treatment visits
3 secondary outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Up to 24 weeks
Vancouver Scar Scale (VSS)
Time frame: Up to 24 weeks
Ease of wound management
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBPM10 System and Massages with vitamin E cream in people with Post-surgical Wounds, run by KLOX Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, Serious adverse events, device incidents and compliance (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.