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Injectable Collagenase For Burns' Associated Contracture

NCT01237964 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-11-10

No results posted yet for this study

Summary

A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures which result's from burn's healing process.

So far, treatment of choice in patients with burn's created movement limiting contractures, concentrated around supportive care. Patients were referred to surgical intervention only if necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done under such conditions.

This study might introduce a new kind of treatment, which can be done in ambulatory environment .This type of treatment might significantly improve patients' function and quality of life, with no need for a surgical intervention.

Conditions

  • Burn's Associated Contracture

Interventions

DRUG

Xiaflex (FDA approved collagenase)

0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237964 on ClinicalTrials.gov