Endermotherapy With Burn Hypertrophic Scars

NCT03697447 | Completed

• 1 other identifier: 15.374
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scar

Outcome Measures

Primary Outcomes (1)

• Skin Thickness Changes

  Ultrasound skin measures, mm

  baseline, 12, 24 and 36 weeks

Secondary Outcomes (4)

• Cutometer Skin Elasticity Changes

  baseline, 12, 24 and 36 weeks

• Mexameter Skin Erythema Changes

  baseline, 12, 24 and 36 weeks

• Itch Visual Analog Subjective Changes

  baseline, 12, 24 and 36 weeks

• Pain Visual Analog Subjective Changes: VAS

  baseline, 12, 24 and 36 weeks

Study Arms (2)

Endermotherapy treated scar

EXPERIMENTAL

Endermotherapy massage treatment

Procedure: Endermotherapy

Control scar

NO INTERVENTION

No intervention, standard of care

Interventions

Endermotherapy PROCEDURE

Endermotherapy massage (mechanic massage) of burn scar

Endermotherapy treated scar

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Montreal Burn Unit

Montreal, Quebec, H2X 1C9, Canada

Location

Study Officials

• Bernadette Nedelec, PhD

  CRCHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: October 5, 2018
• Study Start: February 13, 2017
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)