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Endermotherapy With Burn Hypertrophic Scars

Primary Purpose

Burn Scar

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endermotherapy
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Scar

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • females and males, of any race, 14 years or older,
  • a thermal injury,
  • at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
  • at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and
  • signed the informed patient consent form

Exclusion Criteria:

  • subjects who have keloids,
  • with a diagnosis of psychiatric illness clearly documented in their medical file,
  • mechanism of injury is an electrical, chemical, or cold injury,
  • a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
  • a suspected or known allergy to ultrasound gel,
  • unable to understand French or English, or
  • subjects who refuse to give informed consent.

Sites / Locations

  • Montreal Burn UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endermotherapy treated scar

Control scar

Arm Description

Endermotherapy massage treatment

No intervention, standard of care

Outcomes

Primary Outcome Measures

Skin Thickness Changes
Ultrasound skin measures, mm

Secondary Outcome Measures

Cutometer Skin Elasticity Changes
skin elasticity measures (r0- cutometer), mm
Mexameter Skin Erythema Changes
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Itch Visual Analog Subjective Changes
Itch, Visual analog scale (score 0-none to 10-worse)
Pain Visual Analog Subjective Changes: VAS
Pain, Visual analog scale (score 0-none to 10-worse)

Full Information

First Posted
March 22, 2018
Last Updated
November 21, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03697447
Brief Title
Endermotherapy With Burn Hypertrophic Scars
Official Title
Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
February 13, 2025 (Anticipated)
Study Completion Date
March 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.
Detailed Description
Patients will receive 12 weeks of endermotherapy , 3 times a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endermotherapy treated scar
Arm Type
Experimental
Arm Description
Endermotherapy massage treatment
Arm Title
Control scar
Arm Type
No Intervention
Arm Description
No intervention, standard of care
Intervention Type
Procedure
Intervention Name(s)
Endermotherapy
Intervention Description
Endermotherapy massage (mechanic massage) of burn scar
Primary Outcome Measure Information:
Title
Skin Thickness Changes
Description
Ultrasound skin measures, mm
Time Frame
baseline, 12, 24 and 36 weeks
Secondary Outcome Measure Information:
Title
Cutometer Skin Elasticity Changes
Description
skin elasticity measures (r0- cutometer), mm
Time Frame
baseline, 12, 24 and 36 weeks
Title
Mexameter Skin Erythema Changes
Description
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Time Frame
baseline, 12, 24 and 36 weeks
Title
Itch Visual Analog Subjective Changes
Description
Itch, Visual analog scale (score 0-none to 10-worse)
Time Frame
baseline, 12, 24 and 36 weeks
Title
Pain Visual Analog Subjective Changes: VAS
Description
Pain, Visual analog scale (score 0-none to 10-worse)
Time Frame
baseline, 12, 24 and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: females and males, of any race, 14 years or older, a thermal injury, at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces, at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and signed the informed patient consent form Exclusion Criteria: subjects who have keloids, with a diagnosis of psychiatric illness clearly documented in their medical file, mechanism of injury is an electrical, chemical, or cold injury, a dermatological conditions in the region of the evaluation site, that may interfere with the study results, a suspected or known allergy to ultrasound gel, unable to understand French or English, or subjects who refuse to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana De Oliveira
Phone
514-288-8201
Ext
4229
Email
ana.de-oliveira.chum@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Nedelec, PhD
Organizational Affiliation
CRCHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Burn Unit
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1C9
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endermotherapy With Burn Hypertrophic Scars

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