Endermotherapy With Burn Hypertrophic Scars

NCT ID: NCT03697447

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2020-02-05

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.

Conditions

Burn Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Endermotherapy treated scar

Endermotherapy massage treatment

Group Type: EXPERIMENTAL

Endermotherapy

Intervention Type: PROCEDURE

Endermotherapy massage (mechanic massage) of burn scar

Control scar

No intervention, standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endermotherapy

Endermotherapy massage (mechanic massage) of burn scar

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernadette Nedelec, PhD

Role: PRINCIPAL_INVESTIGATOR

CRCHUM

Locations

Montreal Burn Unit

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

15.374

Identifier Type: -

Identifier Source: org_study_id