Endermotherapy With Burn Hypertrophic Scars
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators:
Information provided by (Responsible Party):
Bernadette Nedelec，Centre hospitalier de l'Université de Montréal (CHUM)
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | March 22, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | February 13, 2017 | ||
| Estimated Primary Completion Date | February 13, 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Skin Thickness Changes[ Time Frame: baseline, 12, 24 and 36 weeks ] Ultrasound skin measures, mm |
||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
|
||
| Descriptive Information | |||
| Brief Title ICMJE | Endermotherapy With Burn Hypertrophic Scars |
||
| Official Title ICMJE | Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors |
||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
||
| Condition ICMJE | |||
| Intervention ICMJE |
|
||
| Study Arms |
|
||
| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
48 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 13, 2020 | ||
| Estimated Primary Completion Date | February 13, 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
|
||
| Ages | 14 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Canada | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
||
| IPD Sharing Statement |
|
||
| Responsible Party | Bernadette Nedelec，Centre hospitalier de l'Université de Montréal (CHUM) | ||
| Study Sponsor ICMJE | Centre hospitalier de l'Université de Montréal (CHUM) | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
|
||
| PRS Account | Centre hospitalier de l'Université de Montréal (CHUM) | ||
| Verification Date | October 2018 | ||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||
请使用微信扫码报名
京公网安备 11010102003638号