Surgical WoundsNCT02604251

Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds

A study testing KLOX BioPhotonic WoundGel System and Silicone sheets in people with Surgical Wounds, run by KLOX Technologies Inc. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, randomized, prospective, controlled study in patients having bilateral breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX BioPhotonic WoundGel System compared with the ones of Silicone Sheets in the treatment of surgical wounds. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Surgical Wounds
What is being tested?: KLOX BioPhotonic WoundGel System and Silicone sheets
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 2 sitesCanada
Study dates: Oct 2015to Nov 2017
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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent form
Female patients, aged between 18 and 75 years old
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 IV
Patients scheduled to go through bilateral breast reduction and expected to have newly formed post-surgery breast incisions of comparable length, located on comparable skin area
Patients able to understand, willing and able to comply with all study requirements
Patients must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the Study
Females of childbearing potential must not be lactating at Study Screening and agree to use adequate contraceptive method during the Study

Who cannot join

Inability to understand the Study and its requirements or to give informed consent
Patient has participated in any other clinical study within 3 months prior to Study Screening and throughout the Study duration
Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to Study Screening and throughout the Study duration
Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily)
Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures
Female patient pregnant, nursing or planning to become pregnant within the next 18 months

Show all 25Show fewer

Patient is a current smoker or has been smoking or using nicotine product(s) in the last three months
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 with known hypersensitivity to pain medications
Patients with severe elastosis
Patients with severe or cystic acne on the area(s) to be treated
Presence of a metal stent or implant in the area(s) to be treated
Patients with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/deep chemical peeling, microdermabrasion, laser therapy or prescription level glycolic acid treatment to the treatment area(s) within three months prior to Study Screening or during the Study
Patients anticipating the need for surgery or overnight hospitalization during the course of the Study
Patients with history of keloids or hypertrophic scars
Patients anticipating sun tanning bed or excessive sun exposure during the Study period
Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and right breasts
Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts
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 incisions that are actively bleeding
Patients with history of irradiated breast(s) in the area(s) to be treated.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Victoria Park Medispa
Montreal, Quebec, H3Z1C3
Westmount Aesthetic Surgery Centre
Montreal, Quebec, H3Z2M5

Other trials in Canada

About this study

Official title: A Prospective Randomized Clinical Study Evaluating the Safety and Efficacy of the KLOX BioPhotonic WoundGel System When Compared With Silicone Sheets in the Treatment of Surgical Wounds

Conditions: Surgical Wounds
Being tested: KLOX BioPhotonic WoundGel System, Silicone sheets
Medical subject headings: Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KLOX BioPhotonic WoundGel SystemDevice
Patients will then be re-randomized to one of the three comparisons: treatment starting on day 7 post-surgery, treatment starting on Day 21 post-surgery, or two consecutive treatments applied once weekly.
Silicone sheetsDevice
Treatment of the surgical wounds with silicone sheets.

Study groups in NCT02604251
Study group	Role	What they receive
Treatment with KLOX BioPhotonic WoundGel System	Experimental	One breast will be randomized to be treated with KLOX BioPhotonic WoundGel System. Receives: Device: KLOX BioPhotonic WoundGel System
Treatment with silicone sheets	Active comparator	The second breast will be randomized to be treated with silicone sheets. Receives: Device: Silicone sheets

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events, Serious Adverse Events and Device Incidents
Number of patients with adverse events, serious adverse events and device incidents
Measured: 24 weeks

Secondary outcomes (4)

Patient and Observer Scar Assessment Scale (POSAS)
Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the patient and by the investigator via the POSAS
Measured: up to 24 weeks
Vancouver Scar Scale (VSS)
Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by the investigator via the VSS
Measured: up to 24 weeks
Efficacy as assessed by blinded experts panel
Assessment of the efficacy of the KLOX BioPhotonic WoundGel System and of Silicone Sheets by a blinded experts committee
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.

Oct 2015Nov 2017

First posted13 Nov 2015 (estimated)
Study startOct 2015
Primary completionApr 2017
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02604251
Sponsor's protocol ID: CL-K1002-P010
Status last verified: Mar 2018
First submitted: 6 Nov 2015
Last updated: 6 Mar 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Wounds trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Clinical Study Evaluating the Safety and Efficacy of the KLOX BioPhotonic WoundGel System When Compared With Silicone Sheets in the Treatment of Surgical Wounds
ClinicalTrials.gov ID: NCT02604251
Acronym / sponsor ID: CL-K1002-P010
Conditions: Surgical Wounds
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: KLOX Technologies Inc.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Apr 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 13 Nov 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment with KLOX BioPhotonic WoundGel System	Experimental	Device: KLOX BioPhotonic WoundGel SystemOne breast will be randomized to be treated with KLOX BioPhotonic WoundGel System.
Treatment with silicone sheets	Active comparator	Device: Silicone sheetsThe second breast will be randomized to be treated with silicone sheets.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed and dated written informed consent form
Female patients, aged between 18 and 75 years old
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 IV
Patients scheduled to go through bilateral breast reduction and expected to have newly formed post-surgery breast incisions of comparable length, located on comparable skin area

Key exclusion criteria (25 listed)

Inability to understand the Study and its requirements or to give informed consent
Patient has participated in any other clinical study within 3 months prior to Study Screening and throughout the Study duration
Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to Study Screening and throughout the Study duration
Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily)
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
KLOX BioPhotonic WoundGel SystemPatients will then be re-randomized to one of the three comparisons: treatment starting on day 7 post-surgery, treatment starting on Day 21 post-surgery, or two consecutive treatments applied once weekly.	Device	Treatment with KLOX BioPhotonic WoundGel System
Silicone sheetsTreatment of the surgical wounds with silicone sheets.	Device	Treatment with silicone sheets

Primary outcome

Adverse Events, Serious Adverse Events and Device Incidents
Time frame: 24 weeks
Number of patients with adverse events, serious adverse events and device incidents

4 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
Efficacy as assessed by blinded experts panel
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 6 Mar 2018.

Related trials for Surgical Wounds

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Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
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RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing KLOX BioPhotonic WoundGel System and Silicone sheets in people with Surgical Wounds, run by KLOX Technologies Inc. at 2 sites 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 8 inclusion and 25 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 and Device Incidents (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02604251.

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 6 Mar 2018.