Clinical Trial: Injectable Collagenase For Burns' Associated Contracture

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture

Brief 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.

Detailed Summary:

Scientific Background:

Contracture is defined as a scar tissue that replaces the original tissue and leads to shortening and tightening of the muscle results in a range of motion limitation and deformity. Contracture creation is common in burn's healing process. The process itself involves fibrosis of the effected area including intrusion towards the deep layers of the skin, and can be described as ineffective healing process. In many cases these scars have major functional and cosmetic implications that challenges the plastic surgery departments around the world.

Creation of bands, webs and contractures close to a joint area can cause a significant movement limitation and shortens the range of motion. Until recently, failure of treatment with bandaging, splints and physiotherapy activity usually led to surgical intervention involving many kinds of techniques ranging from simple incisions, Z-Plasties to skin grafts, and flaps. All these methods were meant to release the contracture itself and restore the functional capability.

A recent study showed that it's possible to use the collagenase enzyme in releasing dupuytren's contracture by a simple injection, a procedure that can be preformed under ambulatory conditions. This kind of contracture causes a fixed flexion of the fingers towards the palm of the hand. The study was a double blinded, placebo controlled study and involved 308 patients, all suffered from contracture with at least 20 degrees range of movement limitation. In the end, it was proved beyond any doubt that collagenase is effective in releasing and restoring range of motion of dupuytren's contracture. These positive results might indicate the possibility of using collagenase in other kinds of contractures.

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Sponsor: Sheba Medical Center

Current Primary Outcome:

• Increase functionality of involved joint [ Time Frame: 24 hours after injection ]
  range of motion of the joint involved will be measured using Goniometer
• Pain assessment [ Time Frame: 24 hours after injection ]
  will be measured using VAS pain scale
• Increase functionality of involved joint [ Time Frame: 14 days after injection ]
  range of motion of the joint involved will be measured using Goniometer
• Increase functionality of involved joint [ Time Frame: 28 days after injection ]
  range of motion of the joint involved will be measured using Goniometer
• Pain assessment [ Time Frame: 14 days after injection ]
  will be measured using VAS pain scale
• Pain assessment [ Time Frame: 28 days after injection ]
  will be measured using VAS pain scale

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sheba Medical Center

Dates:
Date Received: November 3, 2010
Date Started: March 2011
Date Completion: August 2011
Last Updated: November 9, 2010
Last Verified: November 2010