Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Brief Summary

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Once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function.

Thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products

Detailed Description

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This is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study MW2004-11-02 (previous phase 3 study).

We had previously shown that by using the MVSS scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in Debrase vs. SOC group were observed in sub-groups of highly functional body parts of the hands and feet. This study will include specific functionality evaluation using the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).

Conditions

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Burns, Upper Extremity Burns, Lower Extremity

Keywords

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Functionality extremities ROM Upper and lower Extremity for burned patients

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Debrase

Patients previously treated with Debrase for burn debridement

No interventions assigned to this group

Standard of Care

Patients previously treated with local Standard of Care for burn debridement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults and children who had participated and completed study MW2004-11-02. Patients must be able to sign and dated written informed consent prior to study entry (by Patient or by a guardian, when applicable).

Exclusion Criteria

* None

Minimum Eligible Age

10 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Koller, PhD

Role: PRINCIPAL_INVESTIGATOR

Department Head of Burs and Reconstructive Surgery

Locations

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Clinic of Burns and reconstructive surgery hospital

Košice, , Slovakia

Site Status

Countries

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Slovakia

Central Contacts

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Keren David, MSc

Role: CONTACT

Phone: +972-8-9324003

Email: [email protected]

Efrat Hazan, BSc