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

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.

In this study the investigators intend to perform a preliminary test of the effectiveness of collagenase in treating contracture that developed due to the burn's healing process. As comparison parameters the investigators will compare the range of motion before and after treatment and subjective feeling of pain (again, before and after treatment) according to VAS scale of pain. Also the investigators will try to monitor any kind of side effects that might appear.