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

NCT03271164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-02-26

No results posted yet for this 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.

Conditions

  • Post-surgical Wounds

Interventions

DEVICE

FBPM10 System

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

OTHER

Massages with vitamin E cream

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

Sponsors & Collaborators

  • KLOX Technologies Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2018-02-28
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03271164 on ClinicalTrials.gov